U.S. patent application number 15/968819 was filed with the patent office on 2018-09-06 for surgical stapler.
The applicant listed for this patent is JustRight Surgical, LLC. Invention is credited to Joseph D. Bucciaglia, Richard N. Granger, Allison B. Lyle, Robert E. Schneider, Robert J. Smith.
Application Number | 20180250006 15/968819 |
Document ID | / |
Family ID | 56097275 |
Filed Date | 2018-09-06 |
United States Patent
Application |
20180250006 |
Kind Code |
A1 |
Bucciaglia; Joseph D. ; et
al. |
September 6, 2018 |
SURGICAL STAPLER
Abstract
A cartridge for a surgical stapler has an elongated body having
a first side with a tissue clamping interface and a second side.
The elongated body is configured to removably house a plurality of
B-form staples, at least one of the plurality of B-form staples
having a base and a leg. The elongated body has a first slot shaped
to receive a translating cutting mechanism, the first slot passing
through the first side and the second side. The elongated body has
a second slot shaped to house at least a first one of the plurality
of staples; and a third slot shaped to house at least a second one
of the plurality of staples at an angle oblique to the first one of
the plurality of staples.
Inventors: |
Bucciaglia; Joseph D.;
(Boulder, CO) ; Granger; Richard N.; (Niwot,
CO) ; Lyle; Allison B.; (Boulder, CO) ;
Schneider; Robert E.; (Erie, CO) ; Smith; Robert
J.; (Louisville, CO) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
JustRight Surgical, LLC |
Louisville |
CO |
US |
|
|
Family ID: |
56097275 |
Appl. No.: |
15/968819 |
Filed: |
May 2, 2018 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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15916503 |
Mar 9, 2018 |
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15968819 |
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15827250 |
Nov 30, 2017 |
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15916503 |
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15148744 |
May 6, 2016 |
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15827250 |
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62159191 |
May 8, 2015 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 17/07207 20130101;
A61B 2017/07228 20130101; A61B 2017/07271 20130101; A61B 2017/07214
20130101; A61B 2017/07257 20130101; A61B 17/105 20130101; A61B
2017/07278 20130101; A61B 2017/07221 20130101; A61B 2017/07285
20130101 |
International
Class: |
A61B 17/072 20060101
A61B017/072; A61B 17/10 20060101 A61B017/10 |
Claims
1. A cartridge for a surgical stapler, comprising: an elongated
body having a first side with a tissue clamping interface and a
second side, the elongated body configured to removably house a
plurality of B-form staples, at least one of the plurality of
B-form staples having a base and a leg; wherein the elongated body
further comprises a first slot shaped to receive a translating
cutting mechanism, the first slot passing through the first side
and the second side; a second slot shaped to house at least a first
one of the plurality of staples; and a third slot shaped to house
at least a second one of the plurality of staples at an angle
oblique to the first one of the plurality of staples.
2. The cartridge of claim 1, further comprising: the tissue
clamping interface is a curved tissue clamping interface; and
wherein the oblique angle is between 4 degrees and 30 degrees.
3. The cartridge of claim 1, wherein: the second slot is shaped to
translatably house at least a first staple pusher; the third slot
is shaped to translatably house at least a second staple pusher;
and the second slot and the third slot are configured to limit the
first staple pusher to translation at an angle oblique to
translation of the second staple pusher.
4. The cartridge of claim 1, wherein: the second slot houses at
least a first staple pusher and the first one of the plurality of
staples; and the first staple pusher is shaped to position the base
of the first one of the plurality of staples in contact with the
elongated body.
4. The cartridge of claim 4, wherein: the elongated body is coupled
to a support jaw; and one of at least one of the plurality of
staples has a leg length of 3.42 mm or greater, and the cartridge
is shaped to fit within an envelope diameter of 5.6 mm or less at
least one of the plurality of staples has a leg length of 4.72 mm
or greater, and the cartridge is shaped to fit within an envelope
diameter of 8.6 mm or less.
5. The cartridge of claim 4, wherein: the second slot is shaped to
slidably receive a first longitudinally translating cam to
effectuate a sliding motion of the first staple pusher; and the
third slot is shaped to slidably receive a second longitudinally
translating cam to effectuate a sliding motion of a second staple
pusher oblique to the sliding motion of the first staple
pusher.
7. The cartridge of claim 1, wherein: the cartridge comprises a
curved tissue clamping interface; and the cartridge is configured
to position at least one of the plurality of staples at an angle
normal to the curved tissue clamping interface.
6. The cartridge of claim 7, wherein: the curved tissue clamping
interface is curved about a longitudinal axis extending between a
proximal end and a distal end of the elongated body.
7. The cartridge of claim 8, wherein: the elongated body is coupled
to a support jaw, the elongated body and the support jaw having an
envelope diameter; the envelope diameter is 5.6 mm or less; and at
least the first one of the plurality of staples has a leg length of
3.42 mm or greater.
8. The cartridge of claim 1, wherein: the elongated body is coupled
to a support jaw; and one of: at least the first one of the
plurality of staples has a leg length of 3.42 mm or greater, and
the cartridge has an envelope diameter of 5.6 mm or less; or at
least the first one of the plurality of staples has a leg length of
4.72 mm or greater, and the cartridge has an envelope diameter of
8.6 mm or less.
11. The cartridge of claim 1, wherein: the second slot houses a
first staple pusher having a cupped portion, and the first one of
the plurality of staples; wherein the cupped portion and a wall of
the second slot guide the base of the first one of the plurality of
staples as the first one of the plurality of staples is translated
relative to the elongated body.
9. The cartridge of claim 1, further comprising: a recess for
coupling to a cartridge support jaw; and wherein the cartridge and
the support jaw are shaped to fit within an envelope diameter of
5.6 mm or less.
10. The cartridge of claim 1, further comprising: a curved tissue
clamping interface.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of application Ser. No.
15/916,503 filed Mar. 9, 2018 and entitled "SURGICAL STAPLER",
which is a continuation of application Ser. No. 15/827,250 filed
Nov. 30, 2017 and entitled "SURGICAL STAPLER", which is a
continuation of Ser. No. 15/148,744, filed May 6, 2016, and
entitled "SURGICAL STAPLER", which claims priority to U.S.
Provisional Application No. 62/159,191, filed May 8, 2015 and
entitled "SURGICAL STAPLER," the entire disclosures of which are
hereby incorporated by reference for all proper purposes.
BACKGROUND
[0002] A surgical stapler is a medical device which is used to
place surgical staples in a patient to close wounds ranging from
bowel resections to skin incisions and others.
[0003] The staples to be applied to the tissue must be selected
based on the thickness of the tissue to be stapled. Generally,
larger staples require the use of surgical staplers that are also
larger. For example, one 5 mm stapler sold under the trademark
JustRight.TM., has a nominal shaft diameter of about 5 mm, and is
currently indicated for applying staples having a nominal leg
length of about 2 mm. Put another way, the 5 mm JustRight.TM.
Surgical Stapler is indicated for use in procedures in which the
tissue can be clamped between the stapler jaws to about 1 mm or
less. JustRight.TM. is a trademark belonging to the assignee of
this application.
[0004] Some currently-available staplers, such as a stapler sold
under the trademarks Cardica.TM. MicroCutter Xchange.RTM. 30, do
not use staples defined by a leg length; nonetheless, these
staplers are similarly limited in that the staplers cannot staple
tissue if the tissue cannot be clamped to a certain thickness.
Should the surgeon need to staple tissue clamped to, for example, 2
mm, the surgeon would be required to use a stapler that is around
12 mm in diameter.
[0005] Some manufacturers have attempted to provide a relatively
small stapler that may staple relatively thick tissue, such as the
Cardica.TM. stapler described above. However, these staplers use
what are known as D-shaped staples, as illustrated in FIGS.
35A-35B, instead of the more common B-form staples, which are
illustrated in FIGS. 35C-35D. The D-shaped staples have relatively
thick legs, with one of the legs not having a piercing feature, and
have not been subject to extensive field use. It is believed by the
Inventors that, for a given tissue thickness, the D-shaped staples
introduce more trauma to the patient than do the B-form
staples.
[0006] While the use of a larger stapler for placing larger staples
is often acceptable, in certain medical procedures, such as in
procedures performed on small or weak patients, such as small
children or those with physical or disease trauma, it may be
desirable to use a relatively small shaft surgical device to staple
tissue that is relatively thick, using a B-form staple.
[0007] Moreover, it is known that, if a surgeon clamps onto too
much tissue for a given staple leg length or indicated use,
currently-available staplers could still fire the staples and cut
the tissue improperly. That is, the currently-available staplers
could fire the staples, and thereafter cut the tissue, leaving the
site open. It may therefore be desirable to provide a stapler that
does not leave the site open or unsealed if the staples are not
properly placed.
[0008] It may also be desirable to provide a surgeon the ability to
create a wider cuff (that is, a larger tissue margin between the
staples and transection line) for a given clamped tissue thickness
than is possible using the currently-available surgical
devices.
[0009] There therefore remains a need for a relatively small
surgical stapler capable of stapling relatively thick tissue using
B-form staples and/or providing a relatively wider cuff, with less
impact to the patient, as well as other new and innovative
features.
FIELD
[0010] The present disclosure relates generally to surgical
instruments, and more specifically to endosurgical staplers and/or
methods of placing surgical staples in a patient.
SUMMARY
[0011] An exemplary cartridge for a surgical stapler has an
elongated body having a first side with a tissue clamping interface
and a second side, the elongated body configured to removably house
a plurality of B-form staples. At least one of the plurality of
B-form staples has a base and a leg. The elongated body has a first
slot shaped to receive a translating cutting mechanism, the first
slot passing through the first side and the second side. The
elongated body has a second slot shaped to house at least a first
one of the plurality of staples. The elongated body has a third
slot shaped to house at least a second one of the plurality of
staples at an angle oblique to the first one of the plurality of
staples.
BRIEF DESCRIPTION OF THE DRAWINGS
[0012] FIG. 1A is a perspective view of a surgical stapler coupled
to an actuator;
[0013] FIG. 1B is a perspective view of the surgical stapler in
FIG. 1A;
[0014] FIG. 2 is an exploded perspective view of the surgical
stapler in FIG. 1B;
[0015] FIG. 3 is a perspective view of a cartridge in the stapler
in FIG. 1B;
[0016] FIG. 4 is a cross-section view of the cartridge in FIG.
3;
[0017] FIG. 5 is another cross-section view of the cartridge in
FIG. 3;
[0018] FIG. 6 is a top view of the cartridge in FIG. 3;
[0019] FIG. 7 is a rotated top view of the cartridge in FIG. 3;
[0020] FIG. 8 is a perspective view of an anvil in the stapler in
FIG. 1B;
[0021] FIG. 9 is a top view of the anvil in FIG. 8;
[0022] FIG. 10 is a bottom view of the anvil in FIG. 8;
[0023] FIG. 11 is a back view of the anvil in FIG. 8;
[0024] FIG. 12 is a perspective view of features in the anvil in
FIG. 8;
[0025] FIG. 13 is a perspective view of features in the anvil in
FIG. 8;
[0026] FIG. 14 is a cross-section view of a cartridge and anvil
suitable for the stapler in FIG. 1B;
[0027] FIG. 15 is a side view of features of the stapler in FIG.
1B;
[0028] FIG. 16 is a side view of features of the stapler in FIG.
1B;
[0029] FIG. 17 is a side view of features of the stapler in FIG.
1B;
[0030] FIG. 18 is a perspective view of a cutting mechanism in the
stapler in FIG. 1B;
[0031] FIG. 19 is a perspective view of a cutting mechanism in the
stapler in FIG. 1B;
[0032] FIG. 20A is a perspective view of the stapler in FIG.
1B;
[0033] FIG. 20B is a perspective view of the stapler in FIG.
1B;
[0034] FIG. 20C is a perspective view of the stapler in FIG.
1B;
[0035] FIG. 21 is a cross-section view of a clamp suitable for a
stapler;
[0036] FIG. 22 is a perspective view of a staple pusher in the
stapler in FIG. 1B;
[0037] FIG. 23 is a first side view of the staple pusher in FIG.
22;
[0038] FIG. 24 is a second side view of the staple pusher in FIG.
22;
[0039] FIG. 25 is a perspective view of a lower anvil positioner in
the stapler in FIG. 1B;
[0040] FIG. 26 is a perspective view of some components of the
stapler in FIG. 1B;
[0041] FIG. 27 is a side section view of some components of a
stapler;
[0042] FIG. 28 is a perspective view of an integrated housing;
[0043] FIG. 29 is a cross-section view of a cartridge, staple
pushers, and staples;
[0044] FIG. 30 is a detailed view of the components in FIG. 29;
[0045] FIG. 31 is a cross-section view of a cartridge, staple
pusher, and staples;
[0046] FIG. 32 is a detailed view of the components in FIG. 31;
[0047] FIG. 33 is a cross-section view of a clamp and other
components;
[0048] FIG. 34 is a cross-section perspective view of the clamp and
other components;
[0049] FIG. 35A is a side view of a D-shaped surgical staple prior
to placement;
[0050] FIG. 35B is a side view of the D-shaped staple in FIG. 35A
in a placed configuration;
[0051] FIG. 35C is a side view of a B-form surgical staple prior to
placement;
[0052] FIG. 35D is a side view of the B-form staple in FIG. 35C in
a placed configuration; and
[0053] FIG. 36 is a flowchart of an exemplary method.
DETAILED DESCRIPTION
[0054] To meet the previously-described needs, and/or to provide
other new and useful features, a surgical stapler and method may be
provided, and this paragraph is intended to be a conceptual
overview, so as to give the reader a better understanding of the
detailed description that follows. In some examples, a surgical
stapler having a relatively small size is provided, and configured
to place relatively large staples in a patient. This may be
achieved by housing the staples at an oblique angle relative to
each other or a common datum, such as a longitudinal axis or
transection line. That is, instead of housing the staples parallel
to each other (and/or perpendicular to a flat tissue clamping
interface), as is known in the art, the Inventors provide, in some
examples, a system in which the staples may be housed at a non-zero
angle relative to each other or a common datum, and directed to
staple tissue clamped between a curved jaw/cartridge and a curved
anvil. This configuration gives surgeons the previously-unavailable
option of placing relatively large staples using a relatively small
stapler. Put another way, this configuration gives surgeons the
previously--unavailable option of stapling tissue using a device
gap of more than 1.0 mm using a 5 mm stapler (nominal).
[0055] For the purpose of this document, the term "nominal" shall
refer to a range of dimensions usual in the medical device and/or
surgical stapler industry at the time of invention or at the time
of manufacture, whichever range is greater. For example,
currently-available 5 mm staplers (nominal) are known to vary
across manufacturers from 5.0 to 6.0 mm or 5.5+/-0.5 mm. As another
example, a cannula having a nominal inner diameter of 5.5 mm is
known to have an actual inner diameter of at least 5.59 mm as of
the time of this writing, but may be greater as of the time of
manufacture. A staple having a nominal leg length of 3.5 mm is
known to have an actual leg length that varies by about +/-0.08 mm
as of the time of this writing. Further, for the purpose of this
document, all absolute terms, such as, for example, flat, parallel,
perpendicular, round, etc., as well as all dimensions, shall be
understood to include the limitation "within reasonable
manufacturing tolerances a t the time of the invention or at the
time of manufacture, whichever are greater". For the purpose of
this document, the term "proximal" shall refer to that portion or
region of an instrument that is positioned closer to an intended
user, such as a surgeon, and the term "distal" shall refer to the
end or region away from the user or surgeon.
[0056] Turning now to FIG. 1, it illustrates an exemplary
endosurgical stapler 100 passing through a cannula 400 in a manner
known in the art and coupled to a stapler actuator 800. The
interior diameter of the cannula 400 may be a nominal diameter of
5.0 mm or 5.5 mm, which may be up to 6.0 mm with manufacturing
tolerances or standards known in the art. Those skilled in the art
will understand that the cannula 400 is placed in the patient to
provide a port through which the surgeon may access the patient
using the stapler 100. The stapler 100 may have an anvil 102 that
is configured to open or close relative to a support jaw 103. The
support jaw 103 may include a cartridge housing 104, which houses a
cartridge 106. In some embodiments, the housing 104 and cartridge
106 may be a unitary feature referenced as a support jaw 103. The
anvil 102 and support jaw 103 may be coupled to or manipulated at a
proximal region by way of a shaft 116 that houses actuators and/or
other control mechanisms in a manner substantially as is known in
the art.
[0057] To operate the anvil 102, an upper anvil positioner 110 and
a lower anvil positioner 112 may be provided. The anvil positioners
110, 112 may operate to move the anvil 102 between an open
position, a clamped position, and a closed position in a
coordinated manner, and as will be described in further detail in
subsequent sections of this document (see e.g. FIGS. 15-17).
[0058] Continuing with FIG. 1, a cutting mechanism 108 may be
provided and movable relative to the distal portion of the stapler
100, to cut stapled tissue held between the anvil 102 and the
support jaw 103 in a manner to be described in further detail in
subsequent sections.
[0059] Those skilled in the art will readily appreciate that the
components of the stapler 100 in FIG. 1 can be manufactured from
any number of suitable materials, and, more particularly, that the
materials must be selected with a suitable strength so as to
withstand the forces required to clamp and staple relatively large
bands of tissue using relatively small features. For example, any
number of engineering materials, including, but not limited to,
high-strength surgical steels, ceramics, and/or polymers may be
selected.
[0060] In some embodiments, the surgical stapler 100 may have a
housing 104, a portion thereof having an envelope diameter of about
5.5 millimeters or configured to pass through a 5.5 mm cannula
400.
[0061] In some embodiments, a 5.5 mm nominal housing 104 may house
or carry a staple having a 3.0 mm nominal leg length in a manner as
previously described herein. In some embodiments, the staple has a
4.8 mm nominal leg length. In some embodiments, the staple has a
2.0 mm nominal leg length. In some embodiments, the staple has a
2.5 mm nominal leg length.
[0062] Turning now to FIG. 2, further details of the stapler 100 in
FIG. 1 are illustrated in an exploded perspective view. As can be
appreciated, the cartridge 106 may be configured to house one or
more staple pushers 132 such that, upon being actuated by one or
more cams 128, 130, the staple pushers 132 may guide one or more
staples (not illustrated in FIG. 2) out of the cartridge 106 and
towards the anvil 102, whereby the staples are formed about tissue
clamped between the anvil 102 and the cartridge 106/support jaw
103.
[0063] The cam(s) 128, 130 may be actuated in a manner that is
known to those skilled in the art. That is, in some embodiments, a
standard staple pusher and staple driving concept as is currently
available is used. In some embodiments, an extended cam and a
reduced-size staple pusher may be provided. An extended cam is a
cam that is taller than is historically used in surgical staplers
of comparable size. An extended cam is therefore taller, to drive
relatively large staple(s), such as staples having a leg length of
3.0 mm or greater, but the staple pusher size is of a reduced size
such that the leg length of the staple(s) is greater than the
pusher height, as is illustrated in FIG. 5. Those skilled in the
art will recognize that, where the staple(s) 150 or staple
pusher(s) 132 are housed at an oblique angle e relative to each
other or to a transection line, the cam(s) 128, 130 are at a
similarly defined angle.
[0064] Returning to FIG. 2, the cutting mechanism 108 may have a
first member 118 and a second member 120 that are movable or
expandable relative to each other, and configured to move from a
proximal region of the stapler 100 towards a distal region of the
stapler 100 to cut tissue clamped by the stapler 100. The first
member 118 of the cutting mechanism 108 may be actuated,
controlled, and/or retracted using a first actuator 122, and the
second member 120 of the cutting mechanism 108 may be actuated,
controlled, and/or retracted using a second actuator 124.
[0065] The upper anvil positioner 110 may be actuated using an
upper anvil actuator 126, and the lower anvil positioner 112 may be
actuated using a lower anvil actuator (not illustrated). The lower
anvil positioner 112 may have one or more flanges 112a, 112b
configured to engage multiple surfaces of the anvil 102, to, in
coordination with the upper anvil positioner 110, open, clamp, or
close the anvil 102.
[0066] A spring 113 may be provided so as to maintain the anvil 102
biased towards the closed position even if the surgeon rotates the
stapler 100 upside-down. That is, the spring 113 may prevent the
anvil 102 from opening prior to intentional actuation, and may do
so in a manner substantially as is known in the art.
[0067] With reference now to FIG. 3, the cartridge 106 has an
elongated body 134 having a distal end 136 and a proximal end 138.
The cartridge 106 may be configured to removably house a plurality
of staples (not illustrated in FIG. 3). A first slot 140 may be
provided and shaped to receive a cutting mechanism (e.g. cutting
mechanism 108 in FIG. 2) and/or to connect or receive a clamping or
translating mechanism. With brief reference to FIGS. 1B and 21, a
clamping mechanism may include a first member 118 or an upper
flange 506 configured to apply a moving fulcrum force to the anvil
102 as the clamping mechanism 502 travels distally. In some
embodiments, the clamping mechanism 502 is a cutting mechanism 108
or comprises a cutting portion 206. A second slot 142 shaped to
house at least a first one of the plurality of staples, and a third
slot 144 shaped to house at least a second one of the plurality of
staples may also be provided.
[0068] As illustrated in FIG. 4, the second and third slots 142,
144 may be shaped, configured, or positioned so as to house the
first staple at an angle e oblique to the second slot or staple. In
some embodiments, the angle e between the second slot 142 and the
third slot 144 is between about 4 degrees and about 30 degrees. In
some embodiments, the angle e is between about 10 degrees and about
20 degrees. In some embodiments, the angle e is between about 10
degrees and about 15 degrees. In some embodiments, the angle e is
between about 15 degrees and about 20 degrees. In some embodiments,
the angle e is about 15 degrees plus or minus a suitable
manufacturing tolerance. In some embodiments, the angle e is
between about 12 degrees and about 18 degrees.
[0069] As illustrated in FIG. 5, in some embodiments, the second
slot 142 is shaped to translatably house at least a first staple
pusher 146, and the third slot 144 is shaped to translatably house
at least a second staple pusher 148. The second slot 142 and the
third slot 144 may be configured to limit the first staple pusher
146 to translation at an angle e oblique to a translation of the
second staple pusher 148.
[0070] As is also apparent in FIG. 5, in some embodiments, the
first staple pusher 146 may be configured to support a first staple
150 and a third staple 154, while the second staple pusher 148 may
be configured to support a second staple 152 and a fourth staple
156. The first and third staples 150, 154 may be held substantially
parallel to each other, while the second and fourth staples 152,
156 may be held substantially parallel to each other. The first and
second staple pushers 146, 148 may be housed at an oblique angle e
relative to each other, and the cartridge 106 may be configured to
limit translation of the staple pushers 146, 148 along relative
paths that are oblique to each other.
[0071] The housing 104 or support jaw 103 may have an envelope
diameter D of 5.6 mm or 5.5 mm, and may house or carry staples
having a nominal leg length of 3.0 mm. In some embodiments, the
housing 104 or support jaw 103 may house or carry a plurality of
staples 150, 152, 154, 156 having a nominal leg length of 3.5 mm,
as is illustrated in FIG. 5. The staples 150, 152, 154, 156 may be
housed such that a first staple 150 and a second staple 152 are
carried on opposing sides of a longitudinal axis defined by the
housing 104, cartridge 106, or support jaw 103, or, as illustrated
in FIG. 5, by a slot 140 for a cutting mechanism 108. The first and
second staples 150, 152 may be angled relative to each other such
that the legs of the first staple 150 and the legs of the second
staple 152 form an angle e with each other. The angle e may be an
acute angle e in some embodiments. In some embodiments, the angle e
may be between about 4 degrees and about 30 degrees. In some
embodiments, the staples 150, 152 may be mirrored on either side of
the longitudinal axis or slot 140 such that the first staple 150 is
rotated between about 2 degrees and about 15 degrees from a
vertical orientation or from the slot 140, and the second staple
152 may be rotated in an opposing direction between about 2 degrees
and about 15 degrees from the vertical orientation or slot 140. In
some embodiments, the angle e between the first staple 150 and the
second staple 152 may be up to about 90 degrees. A third staple 154
may be parallel to the first staple 150, and a fourth staple 156
may be parallel to the second staple 152. The third and fourth
staples 154, 156 may be closer to the longitudinal axis than are
the first and second staples 150, 152.
[0072] It should be understood that the surgical stapler 100 may
carry or house more than four staples. The first and second staples
(and third and fourth staples if applicable) 150, 152, 154, 156 may
be near a distal or working end of the surgical stapler 100, while
another set of staples may be more proximal to the user. The
staples 150, 152, 154, 156 may include a plurality of B-form
staples in a staggered formation, so as to provide a suitable
closing of tissue. That is, the staples may be in a formation
wherein a distal leg of a proximal staple is positioned more distal
than is a proximal leg of a distal staple, such that a portion of
the proximal and distal staples are next to each other and a
portion is not. Any suitable number of sets of staples may be
provided.
[0073] With simultaneous reference now to FIGS. 5-7, in some
embodiments, one or more of the staples 150, 152, 154, 156 are
partially cupped or supported by a corner or features 166, 168, 170
in the second or third slots 142, 144. That is, cupped regions 158,
160, 162, 164 in the staple pusher(s) 146, 148 may partially
support the staples 150, 152, 154, 156. In some embodiments, a
cupped region 158 in a first staple pusher 146 may work in unison
with a wall 170 and cupped regions 166, 168 in the elongated body
134 of the cartridge 106 to substantially limit a first staple 150
to translation as the first staple 150 is pushed by way of a cam
(e.g. cam 128 in FIG. 2) and the first staple pusher (e.g. first
staple pusher 146 in FIG. 5). Put another way, in some embodiments,
a wall 170 and cupped regions 166, 168 in the cartridge 106 may
provide primary support or guidance of the staple(s) 150, 152, 154,
156.
[0074] It should be understood that when referencing limiting a
staple 150, 152, 154, 156 to translation, some lateral or
rotational give or motion is generally acceptable. Although only
two staple pushers 146, 148 are described herein, those skilled in
the art will understand that any number of staple pushers 146, 148
may be provided, generally along two paths such as two slots 142,
144 that are on opposing sides of a slot 140 along which tissue is
to be cut, so as to ensure tissue is stapled together on either
side of the cut. The staple pushers 146, 148, slots 142, 144, and
cartridge 106 may be configured to place the staples 150, 152, 154,
156 in two rows of staggered staples 150, 152, 154, 156 to ensure
the stapled portion of the tissue is properly clamped and stapled
shut across the entire transection length.
[0075] With continued reference generally to FIGS. 3-7, the
cartridge 106 and/or stapler 100 may be configured to house or
place staples 150, 152, 154, 156 in a patient, wherein at least one
of the staples 150, 152, 154, 156 has a leg length of 3.42 mm or
greater, or a nominal leg length of 3.5 mm or greater, and the
anvil 102 and the support jaw 103 are configured to pass through a
cannula 400 having an inner diameter of 5.6 mm or less or a nominal
inner diameter of 5 mm or less. In some embodiments, at least one
of the staples 150, 152, 154, 156 has a nominal leg length of 4.8
mm or greater or a leg length of 4.72 mm or greater, and the anvil
102 and the support jaw 103 are configured to pass through a
cannula 400 having a nominal inner diameter of 8 mm or less or an
inner diameter of 8.6 mm or less.
[0076] In some embodiments, the stapler 100 is configured to pass
through a cannula 400 having an inner diameter 402, and the stapler
100 is simultaneously configured to carry at least first and second
staples 150, 152 for placement in a patient, at least one of the
staples 150, 152 having a leg length L that is at least 53% of the
inner diameter 402 of the cannula 400, or at least 53% of an
envelope diameter D of the stapler 100 when the stapler is in a
closed configuration (see e.g. FIG. 1B).
[0077] In some embodiments, the leg length L is at least 58% of the
inner diameter 402 or the envelope diameter D. In some embodiments,
the leg length L is at least 60% of the inner diameter 402 of the
cannula 400 or the envelope diameter D. In some embodiments, the
leg length L is at least 61% of the inner diameter 402 of the
cannula 400 or the envelope diameter D. For example, a staple 150
having a nominal leg length of 4.8 mm and a cannula 400 having a
nominal inner diameter of 8.0 may have a ratio of 4.72/8.6 after
taking into account manufacturing allowances. For example, a staple
150 having a nominal leg length of 4.8 mm and a cannula 400 having
a nominal inner diameter of 8.0 may have a ratio of 4.88/8.0 at a
less-than ideal tolerance stack-up.
[0078] In some embodiments, the leg length L is up to 62% of the
inner diameter of the cannula 400 or the envelope diameter D. In
some embodiments, the leg length L is up to 66% of the inner
diameter 402 of the cannula 400 or the envelope diameter D. For
example, a staple 150 having a nominal leg length of 3.5 mm and a
cannula 400 having a nominal diameter of 5 mm may have a ratio of
3.58/5.0 at a less-than ideal tolerance stack-up. In some
embodiments, the leg length L is between 55% and 67% of the inner
diameter 402.
[0079] In some embodiments, the stapler 100 is configured to (a)
pass through a cannula 400 having an inner diameter 402, (b) place
at least first and second staples 150, 152 in a patient, each of
the staples 150, 152 having a first leg length L1 that is between
55% and 67% of the inner diameter 402 of the cannula 400, and (c)
place at least third and fourth staples 154, 156 in a patient, the
third and fourth staples 154, 156 having a second leg length L2
that is different from the first leg length L1 of the first and
second staples 150, 152. In some embodiments, the first leg length
L1 is at least 57% of the inner diameter 402. In some embodiments,
the first leg length is at least 58% of the inner diameter 402. In
some embodiments, the first leg length is at least 61% of the inner
diameter 402.
[0080] In some embodiments, the stapler 100 is configured to place
a first staple 150 having a first leg length L1 and another staple
156 having a different leg length L2. In some embodiments, the
stapler 100 is configured to place staples having a first leg
length L1 on a first side of a tissue cut, and staples having a
second leg length L2 on a second side of a tissue cut. In some
embodiments, the stapler 100 is configured to place a first staple
having a first leg length L1 and a second staple having a second
leg length L2 on the same side of the tissue cut.
[0081] In some embodiments, the stapler 100 is configured with an
outer envelope diameter D (see e.g. FIG. 1B) sized to pass through
a cannula having an inner diameter 402 when the stapler 100 is in a
closed configuration (see e.g. FIG. 15) wherein the curved
interfaces 202, 204 abut one another. The stapler 100 may be
configured to clamp tissue positioned between the anvil 102 and the
support jaw 103 and compress the tissue to a particular thickness
and/or to limit the tissue to a maximum particular thickness,
herein referred to as a device gap G, between the anvil 102 and the
cartridge 106 (see e.g. FIG. 14). Those skilled in the art will
understand that surgical staplers 100 and the associated staples
are generally sized according to the intended thickness of tissue
to be stapled.
[0082] For the purpose of this document, the device gap G is
defined as the maximum space allowed between the support jaw 103 or
cartridge 106 and the anvil 102 at the time the device fires
staple(s) 150 into tissue.
[0083] In one example, the stapler 100, if positioned about very
thin tissue, may be configured to or allowed to "float" towards
contact between the anvil 102 and support jaw 103 and then, as
staple(s) 150 are fired into the tissue, the stapler 100 may be
configured to allow the staple(s) 150 to bias or push the anvil 102
away from the cartridge 106, up to a maximum device gap G. The
maximum device gap G may be limited to a distance defined by a
translating cutting mechanism 108 (see e.g. FIGS. 14, 20C). The
cutting mechanism 108 may move distally substantially or nearly
simultaneously or in coordination with one or more cam(s) 128, 130,
such as when the staple(s) 150 are fired, so as to prevent the
stapler 100 from opening beyond the maximum device gap G.
[0084] Relatedly, and as another example, the stapler 100, if
positioned about relatively thick tissue, may be configured to
compress the tissue down to the maximum device gap G as the
translating cutting mechanism 108 moves distally. For example, if
the stapler 100 is configured to clamp tissue at a device gap G of
2.0 mm, and the tissue positioned between the stapler 100 is
greater than 2.0 mm, the stapler 100 and/or cutting mechanism 108
may compress the tissue appropriately. Of note, if the tissue
positioned between the anvil 102 and the support jaw 103 is so
thick as to not be compressible to the appropriate device gap G,
the cutting mechanism 108 may be configured to jam or stop
translating into tissue that is not suitably clamped.
[0085] For example, most currently-available 5 mm (nominal)
staplers are indicated for stapling tissue that can be clamped to
less than 1.0 mm, while the Cardica 5 mm stapler (nominal--the
actual size is greater than 5 mm, about 5.8 mm or more) is
indicated for stapling tissue that can easily be clamped to 1.5 mm
or less, and uses D-form staples. In both cases, if the surgeon
wishes to staple tissue having a greater thickness, a larger
stapler must be used. Relatedly, currently-available B-form staples
having a nominal leg length of 3.5 mm are indicated for stapling
tissue that can be clamped to between 1.5 mm and 2.0 mm.
Currently-available B-form staples having a nominal leg length of
4.8 mm are indicated for stapling tissue that can be clamped to 2.0
mm.
[0086] In some embodiments, the envelope diameter D is about 5.5 mm
or about 5.6 mm, and the device gap G is between about 0.75 mm and
about 1.0 mm. In some embodiments, the envelope diameter D is about
5.5 mm or 5.6 mm, and the device gap G is between about 1.0 mm and
about 1.5 mm. In some embodiments, the envelope diameter D is about
5.5 mm or 5.6 mm, and the device gap G is greater than about 1.5
mm, and up to about 2.0 mm. In some embodiments, the envelope
diameter D is about 8.5 mm or 8.6 mm, and the device gap G is about
2.0 mm or greater.
[0087] In some embodiments, the device gap G is 13% of the envelope
diameter D or greater. In some embodiments, the device gap G is 17%
of the envelope diameter D or greater. In some embodiments, the
device gap G is 20% of the envelope diameter D or greater. In some
embodiments, the device gap G is 22% of the envelope diameter D or
greater. In some embodiments, the device gap G is 26.8% of the
envelope diameter D or greater. In some embodiments, the device gap
G is 27.3% of the envelope diameter D or greater. In some
embodiments, the device gap G is about 37% of the envelope diameter
D or less. In some embodiments, the device gap G is between about
18% and about 37% of the envelope diameter D. In some embodiments,
the device gap G is between about 22% and about 37% of the envelope
diameter D. In some embodiments, the device gap G is between about
26.8% and about 35.7% of the envelope diameter D. In some
embodiments, the device gap G is between 27.3% and about 36.4% of
the envelope diameter D.
[0088] In some embodiments, the stapler 100 is modular, as
illustrated in FIG. 2 or FIG. 6. That is, one or more
interchangeable cartridge kits 105 may be provided. For example, a
first cartridge kit 105 having a cartridge 106, one or more staple
pushers 132, and one or more staples (not illustrated) having a
first leg length may be interchangeable with a second cartridge kit
105 having a cartridge 106, one or more staple pushers 132, and one
or more staples (not illustrated) having a second leg length that
is different from the first leg length. In some embodiments, the
cartridge kit(s) 105 is removable from a housing 104 or support jaw
103. In some embodiments, alignment features are provided in the
housing 104, support jaw 103, and/or cartridge 106 to enable
suitable alignment. In some embodiments, the cartridge kit 105 is
removable from the support jaw 103 without the use of tools. In
some embodiments, locking features may be provided in the cartridge
kit 105 so as to prevent removal without the use of a tool. In some
embodiments, the cartridge kit 105, housing 104, anvil 102, cutting
mechanism 108, upper and/or lower anvil positioners 110, 112, and
shaft 116 are removable as a unit from the stapler actuator
800.
[0089] Turning now to FIGS. 8-11, and as illustrated in FIG. 1, the
stapler 100 may have an anvil 102. The anvil 102 may be shaped or
configured to be movable relative to the support jaw 103, for
example, by way of a linkage mechanism 172. The linkage mechanism
172 may include one or more recesses or passages 174 in one of the
anvil 102 or the support jaw 103 (or the housing 104 in the support
jaw 103), configured to engage with one or more corresponding
protrusions 176 (see FIG. 2) in the other one of the anvil 102 or
the support jaw 103 (or the housing 104 in the support jaw 103).
The linkage mechanism 172 may be configured to limit the anvil 102
to rotation and translation relative to the support jaw 103 or
housing 104. The linkage mechanism 172 may be configured to adjust
a pivot point of the anvil 102 as the anvil 102 is rotated relative
to the support jaw 103 or housing 104. FIGS. 8A and 8B illustrate
how the linkage mechanism 172 may include one or more recesses or
passages 174 in the support jaw 103 and one or more protrusions 176
in the anvil 102.
[0090] The linkage mechanism 172 may work in a coordinated manner
with the upper and/or lower anvil positioners 110, 112 so as to
effectuate, enable, and/or limit motion of the anvil 102 to
movement between an open position, a clamped position, and a closed
position (see e.g. FIGS. 15-17). Those skilled in the art will
understand that, although the linkage mechanism 172 is illustrated
as having a passage 174 in the anvil 102 and a protrusion 176 in
the support jaw 103 or housing 104, any number of linkage
mechanisms 172 may be employed.
[0091] In some embodiments, the linkage mechanism 172 includes a
snap-fit between an elastic region of the anvil 102 and the support
jaw 103 or housing 104. For example, the anvil 102 may have a
slight protrusion on one or both sides that correspond to pits,
passages, or recesses in the support jaw 103 or housing 104. During
assembly, the anvil 102 may be caused to flex slightly, so as to
snap-fit to the support jaw 103 or housing 104. In some
embodiments, the elastic region may be created by a thin wall
section in the anvil 102.
[0092] In some embodiments, one or more detents (not illustrated)
may be provided in the anvil 102 and/or support jaw 103, and the
detents may be configured to engage one or more recesses or
passages in the other of the anvil 102 and/or support jaw 103, so
as to enable assembly a tight fit between the anvil 102 and support
jaw 103. A detent/recess/passage may be configured to allow a user,
recycler, and/or manufacturer to disassemble the anvil 102 from the
support jaw 103.
[0093] Continuing with FIG. 8, in some embodiments, the anvil 102
or linkage mechanism 172 may include a tissue stop mechanism 178.
The tissue stop mechanism 178 may be a feature in the anvil 102
and/or the support jaw 103 (or cartridge 106 or housing 104)
configured to prevent tissue from being positioned beyond the
stapling region between the anvil 102 and the support jaw 103. That
is, the tissue stop mechanism 178 is configured to prevent the
stapler 100 from cutting tissue that is not stapled. In some
embodiments, the tissue stop mechanism 178 includes a surface 180
in the anvil 102 that is selected and shaped so as to not engage a
surface 182 in the cartridge 106 (see e.g. FIGS. 14-15) and damage
tissue clamped between the support jaw 103 and the anvil 102 when
the anvil is moved from the open position to the clamped
position.
[0094] The anvil 102 may also have a slot 184 shaped and configured
to receive or guide a cutting mechanism 108 or a member 118, 120 of
a cutting mechanism 108 as the cutting mechanism 108 travels
distally to cut tissue clamped between the support jaw 103 and the
anvil 102. The slot 184 may extend from the proximal region 186 of
the anvil 102 to a position short of the distal end 188 of the
anvil 102. The slot 184 may be shaped to limit the cutting
mechanism 108 or member 118, 120 thereof to translation and/or
prevent the cutting mechanism 108 or member 118, 120 from extending
beyond the distal end 188 of the anvil 102.
[0095] In some embodiments, the anvil 102 has one or more guides
190 (see e.g. FIG. 9), configured to guide the cutting mechanism
108 or member 118, 120 of the cutting mechanism 108 as the cutting
mechanism 108 travels down the anvil 102 (see e.g. FIGS. 20A-20C).
The guides 190 in the anvil 102 may correspond to or engage guides
192 in the cutting mechanism 108. In some embodiments, the guide(s)
190 in the anvil 102 may be one or more recesses 190 that engage
corresponding one or more ridges or protrusions 192 in the upper
member 118 of the cutting mechanism 108, as illustrated.
[0096] In some embodiments, guides 192 in the cutting mechanism 108
may be protrusions that do not extend an entire length of the
cutting mechanism 108 or member 118, 120, so as to reduce friction
between the cutting mechanism 108 or member 118, 120 and the anvil
102.
[0097] In some embodiments, the guide(s) 192 in the cutting
mechanism 108 may be recesses (not illustrated). In some
embodiments, the guide(s) 190 in the anvil 102 may be protrusions
(not illustrated) in the anvil 102. In some embodiments the anvil
102 may have a first guide 190 that is a recess or groove, and a
second guide 190 that is a protrusion or flange (not illustrated).
Those skilled in the art will readily envision any number of means
of providing a first and/or second guide 190 to guide the cutting
mechanism 108 as it travels towards the distal region of the
stapler 100, all of which means are contemplated herein.
[0098] In some embodiments, the anvil 102 is sized so as to fit
through a cannula 400 having a nominal inner diameter of 8.0 mm. In
some embodiments, the anvil 102 is sized so as to fit through a
cannula 400 having an inner diameter of 8.6 mm or less. In some
embodiments, the anvil 102 is sized so as to fit through a cannula
400 having a nominal inner diameter of 5.5 mm. In some embodiments,
the anvil 102 is sized so as to fit through a cannula 400 having an
inner diameter of 5.6 mm or less.
[0099] Continuing with FIGS. 9-13, the anvil 102 may have first
and/or second cam guides 194, 196. The cam guide(s) 194, 196 may be
slots in a portion of the anvil 102 configured to guide one or more
cams 128, 130 (see FIG. 2) as the cam(s) 128, 130 move or translate
longitudinally into the support jaw 103 or housing 104 to cause
motion of the staple pusher(s) 132 and/or the staple(s) 132, 146,
148. The cam guide(s) 194, 196 may assist in maintaining the cam(s)
128, 130 positioned at an angle e relative to each other; for
example, the second and/or third slots 142, 144 in the cartridge
106 and the cam guide(s) 194, 196 may guide the translating cam(s)
128, 130 at an oblique angle e relative to each other, so as to
effectuate motion of the staple pushers 132, 146, 148 at the
oblique angle e relative to each other (see also FIG. 5 illustrated
the cartridge 106). Put another way, the cam guides 1974, 196 may
effectuate a first travel path on a first staple pusher 146 and a
second travel path on a second staple pusher 148, the first travel
path being at an oblique angle e relative to the second travel
path.
[0100] With brief reference to FIGS. 11 and 13, the anvil 102 may
have a curved tissue clamping interface 202, and the cartridge 106
may have a curved tissue clamping interface 204 (see e.g. FIG. 3)
configured to oppose the curved tissue clamping interface 202 of
the anvil 102 when the stapler 100 is in a clamped or closed
configuration (see e.g. FIGS. 15 and 17). That is, in some
embodiments, the anvil 102 may be curved to provide a curved beam
in flexure and utilize the compression strength of the material to
react against the staple forming forces from the opposing sides.
More specifically, the curved beam may prevent the anvil 102 from
undesired deformation; in turn, the curved beam may assist in
proper staple formation. Those skilled in the art will understand
that the term "curved tissue clamping interface" is intended to
reference a generally curved clamping surface that may or may not
be interrupted by one or more recesses, protrusions, and/or flat
regions.
[0101] Together, the curved tissue clamping interfaces 202, 204 may
be configured to clamp tissue therebetween when the anvil 102 is in
the clamped position (illustrated in FIG. 17). The curved tissue
clamping interfaces 202, 204 may be configured to abut or nest
together when the anvil 102 is in the closed position (illustrated
in FIG. 15). In some embodiments, a portion of one or both of the
curved tissue clamping interfaces 202, 204 may have a radius of
curvature R that is between 40% and 60% of the envelope diameter.
For example, for an envelope diameter of 5.6 mm, the radius of
curvature R may be between 2.24 mm and 3.36 mm. In some
embodiments, the envelope diameter D may be about 5.6 mm, and the
radius of curvature R may be between about 2.6 mm and about 2.8 mm.
In some embodiments, the radius of curvature may be about 48% of
the envelope diameter D, or about 2.69 mm where the envelope
diameter D is 5.6 mm.
[0102] A portion of the curved tissue clamping interface 204 in the
cartridge 106 may have a corresponding or similarly constrained
radius of curvature, so as to nest with or clamp tissue with the
anvil 102. In some embodiments, a portion of one or both of the
curved tissue clamping interfaces 202, 204 has a radius of
curvature between 45% and 55% of the envelope diameter. In some
embodiments, the radius of curvature is between 47% and 52% of the
envelope diameter.
[0103] The curved tissue clamping interfaces 202,204 may be
configured to provide a cuff that is larger than a cuff normally
achieved with staplers having similar nominal sizes (e.g. envelope
diameters). Those skilled in the art will understand that a cuff in
stapled and transected tissue is defined as the distance from the
edge of the transected tissue to the first inside staple row. Cuff
width is important because a greater cuff reduces the likelihood
that the tissue will pull through the staples, or that the staples
will tear out. In some embodiments, the cuff width W is greater
than 0.5 mm. In some embodiments, the cuff width W is greater than
0.6 mm. In some embodiments, the cuff width W is about 0.7 mm, or
greater. In some embodiments, the cuff width W is 0.8 mm or
greater. In some embodiments, the cuff width W is 0.9 mm or
greater. In some embodiments, the cuff width W is about 1.6 mm. In
some embodiments, the cuff width W is greater than 0.5 mm up to
about 1.6 mm. In some embodiments, the envelope diameter D is 5.6
mm or less, and the cuff width W is greater than 0.5 mm. In some
embodiments, the envelope diameter D is 5.6 mm or less, and the
cuff width W is about 0.7 mm. In some embodiments, the cuff width W
is a function of the angle e, a radius of curvature of the curved
tissue clamping interfaces 202, 204, and the size of the staples
150. The staples 150 and angle e may be configured based on
currently known standard leg sizes, or as yet to be developed
standard sizes, such as, for example, 2.0 mm, 2.5 mm, 3.0 mm, 3.5
mm, 3.8 mm, 4.1 mm, 4.8 mm, or others.
[0104] Returning now to FIG. 12, the anvil 102 may have one or more
forming pockets 198 configured to form and/or fold the staples(s)
150, 152, 154, 156 as the staple(s) 150, 152, 154, 156 are pushed
out of the cartridge 106 and through tissue, into the anvil 102.
The forming pocket(s) 198 may be configured substantially in a
manner as is known in the art. However, the forming pockets 198 may
be angled or positioned in a manner suitable for properly forming
the staple(s) 150, 152, 154, 156 in embodiments in which the
staple(s) 150, 52, 154, 156 and staple pushers 132, 146, 148
translate at an angle e relative to each other, or embodiments in
which the anvil 102 and cartridge 106 have curved t issue clamping
interfaces 202, 204. The forming pockets 198 may interrupt
engagement of tissue by the curved tissue clamping interface
202.
[0105] Turning now to FIG. 14, in some embodiments, the stapler 100
may provide for a substantially consistent fixed maximum device gap
G across a transverse cross-section of tissue and/or a longitudinal
cross-section of tissue during staple firing and/or tissue
clamping. In some embodiments, the forming pockets 184 in the anvil
102 are shaped and positioned so as to assist in guiding or driving
staples 150, 152, 154, 156 in a direction normal to tissue clamped
between the anvil 102 and cartridge 106 or support jaw 103. In some
embodiments, the stapler 100 has an envelope diameter D of 5.6 mm
or less in a closed configuration, and is configured to allow a
maximum device gap G of greater than 1.5 mm, and up to 2.0 mm
between the curved tissue clamping interfaces 202, 204. In some
embodiments, the stapler 100 has an envelope diameter of 8.6 mm or
less in a closed configuration, and is configured to allow a
maximum device gap G of 2.0 mm or more.
[0106] In some embodiments, the stapler 100 is configured fit
through a cannula 400 having an inner diameter 402 of 5.6 mm or
less in a closed configuration, and to place staples having a
nominal leg length L of 3.5 mm in a patient while allowing a
maximum device gap G of more than 1.5 mm between the curved tissue
clamping interfaces 202, 204. In some embodiments, the stapler 100
is configured to fit through a cannula 400 having an inner diameter
402 of 8.6 mm or less in a closed configuration, and to place
staples having a nominal leg length L of 4.8 mm in a patient and
allow a maximum device gap G of at least 2.0 mm between the curved
tissue clamping interfaces 202, 204.
[0107] In some embodiments, an angle e between a first set of
staples 150, 154 and a second set of staples 152, 156, provides a
relatively wide cuff, as previously described herein. The wider
cuff achieved using a stapler 100 configured for a 5.5 mm cannula
400 may be comparable to a cuff achieved using a standard stapler
configured for a 12 mm diameter cannula 400, and may be about 0.7
mm or more. In some embodiments, a curved cartridge 106 and rotated
or angled staple(s) create additional space between the
knife/cutting mechanism and the inner row of staples, increasing
the width of the tissue "cuff" that is created following staple
formation and tissue transection.
[0108] Continuing with FIG. 14, lead-in features 185 of the forming
pockets 184 may match the rotation angle e of the staples within
the cartridge 106. See also FI G. 10. That is, the lead-in features
185 may be between about 4 degrees and about 30 degrees from each
other, or less than or up to about 90 degrees from each other in
some embodiments. The lead-in features 185 may include any lead-in
means, including bevels, chamfers, reliefs, or any other features
known in the art and configured to assist in guiding staples into
the forming pockets 184.
[0109] Turning now to FIGS. 15-17, as previously described, the
anvil 102 may be movable relative to the support jaw 103 between a
closed position as illustrated in FIG. 15, an open position as
illustrated in FIG. 16, and a clamped position as illustrated in
FIG. 17. In the closed position, the anvil 102 and support jaw 103
may have a compressed envelope dimension or diameter D. That is,
the anvil 102 and support jaw 103 together may be configured to
pass through a passage having an inner dimension of a particular
nominal size. For example, the closed envelope dimension may have a
closed envelope diameter D configured to pass through a cannula 400
having an inner dimension or diameter 402 of a particular nominal
size, such as 8.6 mm or 5.6 mm in some embodiments.
[0110] In some embodiments, the stapler 100 may be tip-biased. That
is, the anvil 102 and/or support jaw 103 may be shaped such that a
distal end of the stapler 100 will tend to contact first when the
stapler 100 is moved towards a closed configuration. A tip-biased
stapler 100 may be configured such that a slight flexure of the
anvil 102 and/or support jaw 103 allows full compression to a
closed configuration wherein the anvil 102 and cartridge 106 make
contact along a substantial or majority portion of the clamping
interfaces 202, 204.
[0111] After passing through or partially through the cannula 400,
the anvil 102 may be actuated to move into an open position, such
as the open position illustrated in FIG. 16. In the open position,
the anvil 102 may be rotated, rotated and translated, or moved such
that a distal portion 188 of the anvil 102 is positioned further
away from the support jaw 103 than is the proximal portion 186.
With the stapler 100 in the open configuration, a surgeon may place
tissue between the support jaw 103 and the anvil 102 in preparation
for surgical cutting and/or stapling of tissue.
[0112] As illustrated in FIG. 17, the anvil 102 may be movable to a
clamped position. The clamped position may be selected or designed
so as to achieve a substantially consistent maximum device gap G
(see e.g. FIGS. 10, 14) between the anvil 102 and the cartridge 106
or support jaw 103, or between the clamping interfaces 202, 204
thereof, during firing and as previously described herein. In some
embodiments, the clamped position may be selected or designed such
that the anvil 102 and support jaw 103 have an envelope dimension
or diameter D2 that is greater in the clamped configuration than
the compressed envelope dimension or diameter D in the closed
configuration. In some embodiments, the clamped configuration
results in an envelope dimension or diameter D that is greater than
the inner diameter 402 or dimension of the cannula 400 through
which the stapler 100 has been passed.
[0113] In some embodiments, an upper anvil positioner 110 and a
lower anvil positioner 112 may be provided and configured to
effectuate motion of the anvil 102 relative to the support jaw 103.
That is, the upper anvil positioner 110 and/or the lower anvil
positioner 112 may be configured to manipulate or move a pivot
point of the anvil 102 as the anvil 102 is moved between the
closed, open, and/or clamped positions.
[0114] Turning now to FIGS. 18-20C, and as previously described,
the stapler 100 may have an expandable cutting mechanism 108 and/or
clamping member configured to move between a collapsed
configuration and an expanded configuration. FIG. 18 illustrates
the cutting mechanism 108 in a collapsed configuration, and FIG. 19
illustrates the cutting mechanism in an expanded configuration.
[0115] In the collapsed configuration (e.g. FIG. 18), the cutting
mechanism 108 may have a height H or envelope diameter that is less
than a combined height of the anvil 102 and the support jaw 103 (or
the rest of the stapler 100 generally) or less than the envelope
diameter D. In the expanded configuration (e.g. FIG. 19), the
cutting mechanism 108 may have or may approach a height H that is
greater than a combined height of the anvil 102 and the support jaw
103 when the anvil 102 is in the clamped configuration. Put another
way, the height H of the cutting mechanism 108 in the collapsed
configuration may be less than the envelope diameter D of the
stapler 100 when the stapler 100 is in the closed and/or clamped
configurations. In some embodiments, the height H of the cutting
mechanism 108 in the collapsed configuration may be less than the
combined envelope diameter of the anvil 102 and the support jaw 103
when the stapler 100 or anvil 102 is in the closed and/or clamped
configurations or positions. In some embodiments, the height H of
the cutting mechanism 108 in the expanded configuration may be
greater than the combined envelope diameter D of the anvil 102 and
the support jaw 103 when the stapler 100 or anvil 102 is in the
closed and/or clamped configuration or position. The height H of
the cutting mechanism 108 in the collapsed configuration may be
less than the inner diameter 402 of the cannula 400. The height H
of the cutting mechanism 108 in the expanded configuration may be
greater than the inner diameter 402 of the cannula 400.
[0116] The expandable cutting mechanism 108 may have a first member
118 and a second member 120 that are expandable, translatable, or
movable relative to each other. In some embodiments, a first one of
the members 118, 120 is movable both longitudinally and
transversely relative to the support jaw 103 or cartridge 106, and
a second one of the members 118, 120 is limited to longitudinal
movement relative to the support jaw 103 or cartridge 106. In some
embodiments, both of the members 118, 120 are movable both
longitudinally and transversely relative to the support jaw 103 or
cartridge 106. In some embodiments, a first one of the members 118,
120 is rotatable relative to a second one of the members 118, 120.
That is, for example, a first member 118, 120 may rotate slightly
as the cutting member 108 expands to move up the anvil 102 and
support jaw 103. The slight rotation may be limited by flanges
and/or legs in the members 118, 120.
[0117] One of the members 118, 120 may have a knife edge or cutting
portion 206, and may be configured to travel through or partially
through a slot 140 in the cartridge 106 and/or a slot 184 in the
anvil 102 so as to cut tissue clamped between the anvil 102 and the
support jaw 103. The other one of the members 118, 120 may be
configured to travel with the first member 118, 120, such that,
together, the first and second members 118, 120 may provide a
strengthening effect on the stapler 100. More specifically, and as
illustrated in FIG. 20C, the cutting mechanism 108 may be
configured to apply a supportive clamping force on tissue clamped
between the anvil 102 and the support jaw 103 when the cutting
mechanism 108 is in a distal position and/or moving distally, and
expanded about the anvil 102 and support jaw 103.
[0118] In some embodiments, the upper anvil positioner 110 is
configured to rotate relative to the support jaw 103 and assist in
guiding the cutting mechanism 108.
[0119] In some embodiments, the expandable cutting mechanism 108 is
coupled to or comprises a first actuator 122 coupled to one of the
members 118, 120, such as the first member 118, and a second
actuator coupled to the other one of the members 118, 129, such as
the second member 120. In some embodiments one or both of the
actuators 122, 124 is flexible. In some embodiments, a first
actuator 122 is configured to apply a retracting force when
actuated (e.g. pull the cutting mechanism 108 towards the user or
proximal region of the stapler 100), and a second actuator 124 is
configured to apply an extending force when actuated (e.g. push the
cutting mechanism 108 away from the user or towards the distal
region of the stapler 100). In some embodiments, a flexible
actuator 122, 124 may be configured with a suitable rigidity for
maintaining the member 118, 120 to which the actuator 122, 124 is
coupled oriented relative to the other member 118, 120. Put another
way, an actuator 122, 124, such as the first actuator 122 may
provide a limited pushing or extending force on the cutting
mechanism 108, and a greater retracting force when retraction is
required.
[0120] In some embodiments, the cutting mechanism 108 is configured
to move between a collapsed configuration wherein the cutting
portion 206 is not in line with a tissue cutting region defined by
the anvil 102 and the support jaw 103 and an expanded configuration
wherein the cutting portion 206 is in line with the tissue cutting
region, the tissue cutting region defined by a device gap G between
the anvil 102 and the support jaw 103 (see e.g. FIGS. 19 and
20A-20C).
[0121] One or both of the actuators 122, 124, (as illustrated, the
first actuator 122) may be configured so as to be flexible enough
to allow the expandable cutting mechanism 108 to expand (e.g. the
first member 118 may move upward and/or the second member 120 may
move downward) as the expandable cutting mechanism 108 travels
distally, and rigid enough to apply a strong enough force to cause
the member 118, 120 to which the actuator 122, 124 is attached to
move distally, or at least remain oriented relative to the other
member. That is, in some embodiments the first actuator 122 may
orient the first member 118 relative to the second member 120 while
the second actuator 124 primarily causes the cutting mechanism 108
to move distally.
[0122] It should be understood that the first and second actuators
122, 124 may be coupled to the first and second members 118, 120
using any means known in the art and suitable for ensuring reliable
control of the first and second members 118, 120. In some
embodiments, one or both actuator(s) 122, 124 has a number of
layers that are fused together, or may comprise a laminated beam.
For example, a plurality of layers 122a, 122b, 122c, 122d
comprising a high strength steel may be provided, and coupled to
each other using a binding agent to achieve a suitable flexibility
in the actuator 122, 124 and extending force on the member 118,
120. In some embodiments, neither actuator 122, 124 has a laminated
beam, but may comprise a material selected for a suitable
flexibility and strength for positioning the cutting mechanism 108
or member 118, 120. That is, the actuator(s) 122, 124 should be
selected so as to be strong enough to push the cutting mechanism
108 or member(s) 118, 120 distally and flexible enough to move with
the cutting mechanism 108 or member(s) 118, 120 as the cutting
mechanism 108 expands outside the envelope diameter D.
[0123] Continuing with FIGS. 18-19, those skilled in the art will
understand that the cutting mechanism 108 may be made of any
suitable materials known in the art and suitable for cutting tissue
clamped between the anvil 102 and the support jaw 103 or cartridge
106. For example, the first member 118 may be formed of a surgical
steel and polished or machined so as to have a sharp cutting
portion 206. In some embodiments, the first member 118 has one or
more legs 208 with a flange portion(s) 210 that are configured to
engage one or more flanges 214 in one or more legs 212 in the
second member 120, so as to limit the amount of expansion possible
between the first and second members 118, 120. In some embodiments,
the legs 208, 212 are configured to allow one member 118, 120 to
rotate a given amount relative to the other member 118, 120. In
some embodiments, the cartridge 106, slot 140, and/or anvil 102 are
configured to maintain a vertical orientation of the cutting
mechanism 108.
[0124] The cutting mechanism 108 may have a means for limiting
expansion between the first and second members 118, 120 to a
pre-determined expanded height H, for example, such that, at
maximum expansion, the cutting mechanism 108 is configured to
assist in preventing the anvil 102 from deforming while clamping
tissue. In some embodiments, the cutting mechanism 108 is
configured to limit a tissue clamping gap between the anvil 102 and
support jaw 103 to a device gap G that is suitable for clamping,
cutting, and/or stapling tissue. For example, in some embodiments,
the cutting mechanism 108 is configured to squeeze the anvil 102
towards the support jaw 103 a given amount as the cutting mechanism
108 travels from a proximal position towards a distal position. As
illustrated most clearly in FIG. 19, in some embodiments, a leading
portion 119 of the first member 118 and/or a leading portion 121 of
the second member 120 may be positioned on the cutting mechanism
108 at a region that is more distal to the user than is the cutting
surface 206. The leading portion(s) 119, 121 may be configured to
apply a compressive force on the anvil 102 and support jaw 103 so
as to ensure the device gap G is reached prior to a tissue cut,
and/or to ensure the maximum device gap G is not exceeded during a
tissue cut.
[0125] In some embodiments, the cutting mechanism 108 is configured
to jam or not travel into a region where the maximum device gap G
is not achieved. For example, if the stapler 100 is configured to
achieve a maximum device gap G of 2.0 mm, but a portion of the
tissue cannot be compressed to 2.0 mm, the cutting mechanism 108
will not travel into regions of tissue that are too thick. In this
event, even if the stapler 100 has inadvertently fired staples into
the tissue, and those staples are not properly formed, the cutting
mechanism 108 will not cut that portion of the tissue that is not
properly stapled. The surgeon may then manually retract the cutting
mechanism 108, and pry the improperly formed staples out of the
tissue.
[0126] As illustrated in FIG. 19, those skilled in the art will
understand that any part of the first member 118 or the second
member 120 may be made unitary, or any part may be a separate
component coupled to other components of the cutting mechanism 108.
In some embodiments, the legs 208, 212 of the members 118, 120 may
be independent features coupled to curved guide portions 118a, 120a
of the members 118, 120.
[0127] With reference now to FIG. 21, in some embodiments, the
surgical stapler 500 may have an anchored clamp mechanism 502 with
a cutting surface 206 as previously described herein. The anchored
clamp mechanism 502 may include a modified I-beam having a first or
lower flange 504 and a second or upper flange 506 coupled together
such that the modified I-beam does not extend all the way through
the diameter of the end effectors, as is the case in
currently-available designs. Instead, the I-beam may be anchored at
the first flange 504 within the cartridge 508, for example, in the
space created by the angle of the staples. In some embodiments, the
I-beam may include a first flange 504 shaped to slidingly engage a
flange or recess in the cartridge 508. The I-beam may include a
surface on one or more of the flanges 504, 506 shaped to slidingly
engage an outer surface of the clamp or end effector of the
surgical stapler 500.
[0128] In some embodiments, the anchored clamp mechanism 502,
cutting mechanism 108, or I-beam may be shaped to slide to trail
the cam(s) 128, 130 and act as a moving fulcrum in a manner
substantially as previously described with reference to the cutting
mechanism 108. In some embodiments, the anchored clamp mechanism
502, cutting mechanism 108, or I-beam may be shaped to slide or
travel distally
[0129] As illustrated in FIG. 21, the first flange 504 may allow
the anchored clamp mechanism to slide through a recess or channel
cutout in the cartridge, while allowing or limiting the maximum
device gap G in a manner substantially as previously described with
reference to the cutting mechanism 108.
[0130] Turning now to FIGS. 22-24, a staple pusher 148 is
illustrated in further detail. The staple pusher 148 may comprise a
first cupped region 160 and a second cupped region 164 configured
to support two staples substantially as previously described
herein. In some embodiments, the cupped regions 160, 164 are
configured to support the staples in a staggered but parallel
orientation, so as to ensure that the stapled tissue is sealed. As
illustrated in FIG. 22, the staple pusher(s) 148 may have a first
cammed surface 216 and/or a second cammed surface 218 that is/are
configured to, in coordination with a translating cam 128, 130 and
the cartridge 106, convert longitudinal motion of the translating
cam 128, 130 into a transverse motion, such as at an angle e
oblique relative to another staple pusher 132 to drive staples into
tissue clamped between the anvil 102 and the support jaw 103.
[0131] FIG. 25 illustrates the lower anvil positioner 112 having,
as previously described, flanges 112a, 112b for assisting in
positioning the anvil 102, although those skilled in the art will
understand that a single flange 112a, 112b may be suitable or
implemented. In some embodiments, the flanges 112a 112b are coupled
together by way of a bridge 112c to enable a single actuator (not
illustrated) to effectuate a motion of the lower anvil positioner
112 and/or flange(s) 112a, 112b. In some embodiments, the lower
anvil positioner 112 has a bridge 112d for coupling the flanges
112a, 112b.
[0132] FIG. 26 illustrates a relationship between the cutting
mechanism 108, the spring 113, and the upper anvil positioner
110.
[0133] As illustrated in FIGS. 27-28, in some embodiments, a
cartridge housing is not provided. That is, a cartridge 106 and
cartridge housing 104 may be integrated in to one piece, an
integrated staple housing 107, to form an outer casing. The
integrated staple housing 107 may have features to properly guide
the staple(s) out of the housing 107 as they are driven by the cam
128, 130 (and staple pusher(s) 132). In embodiments having an
integrated staple housing 107, an insert 109, may be coupled to,
placed in, or snapped into the center of the integrated housing 107
to complete the medial features of the staple pocket 111.
Additionally, the staple pusher(s) 132 may be modified (trimmed) or
suitably sized so as to make space to increase a housing wall
thickness for strength.
[0134] In some embodiments, an integrated staple housing providing
staples guided by the housing walls as illustrated in FIGS. 5
and/or 29-30 may allow for an increase in wall thickness of the
cartridge 508 or housing, and thereby an increased strength of the
surgical stapler as compared to staplers in which the pushers may
cup the staples. Contrast FIGS. 29-30 with FIGS. 31-32.
[0135] In some embodiments, the stapler herein disclosed may be
used in a flexible catheter. In some embodiments, the stapler 100
disclosed herein is configured to couple to or to be used with an
articulating joint.
[0136] As illustrated in FIGS. 20A-20C and/or 33-34, an anchor
clamp mechanism 502 or cutting mechanism 108 may provide a safety
lock feature. In some embodiments, the mechanism 502, 108 may
travel such that that, if too much tissue is clamped (thereby not
achieving the necessary gap previously described herein), the
mechanism 502, 108 is unable to travel down the anvil 102, and will
self-jam, preventing the firing procedure from continuing.
[0137] Turning now to FIG. 36, in some embodiments, a method 3600
of performing a stapling procedure on a patient is provided. The
method 3600 may include providing 3602 a surgical stapler in a
closed position, inserting 3604 at least a portion of the stapler
through a cannula, and moving 3606 the stapler from the closed
position to a clamped position.
[0138] Providing 3602 a surgical stapler in a closed configuration
may include providing a surgical stapler having any of the features
previously described herein with reference to FIGS. 1-35B. In some
embodiments, providing 3602 includes providing a stapler
comprising: an anvil movably coupled to a support jaw; wherein the
support jaw comprises a cartridge having an elongated body having a
distal end and a proximal end and configured to removably house a
plurality of staples. The elongated body may have a first slot
shaped to receive a cutting mechanism, a second slot shaped to
house at least a first one of the plurality of staples, and a third
slot shaped to house at least a second one of the plurality of
staples at an angle oblique to the first one of the plurality of
staples.
[0139] Causing 3604 at least a portion of the surgical stapler to
pass through a cannula may include causing at least a portion of
the stapler to pass through a cannula having an inner diameter. The
cannula may be substantially as previously described herein with
reference to FIGS. 1-35B.
[0140] Causing 3606 the surgical stapler to move from the closed
configuration to the clamped configuration may include causing the
stapler to move to a clamped configuration wherein the surgical
stapler maintains a gap between the anvil and the support jaw, and
the surgical stapler is unable to pass through the cannula. Causing
3606 the stapler to move to the clamped configuration may be
achieved using a stapler as previously described with reference to
FIGS. 1-35B.
[0141] The method 3600 may include stapling tissue using a staple
having a leg length of 3.0 mm or more using a stapler configured to
pass through a cannula 400 that has an inner diameter of 5.6 mm or
less. The method 3600 may include using a stapler that has an
envelope diameter of 5.6 mm or less when in a closed position to
staple tissue clamped to a thickness that is greater than 1.5
mm.
[0142] In some embodiments, the method 3600 further includes
longitudinally translating at least one cam to cause at least one
of a first staple pusher or a second staple pusher in a direction
oblique to the other one of the first staple pusher or the second
staple pusher.
[0143] In some embodiments, the method 3600 further includes
replacing a first cartridge kit in the surgical stapler with a
second cartridge kit. The method 3600 may further include using the
stapler having the first cartridge kit to place first set of a
plurality of staples having a first leg length in a patient,
replacing the cartridge kit, and using the stapler having the
second cartridge kit to place a second set of a plurality of
staples having a second leg length different from the first leg
length in a patient. In some embodiments, the same patient receives
both sets of staples.
[0144] In addition to the description above, various specific
examples are disclosed herein.
Example 1
[0145] A cartridge for a surgical stapler, comprising: an elongated
body configured to fit within an envelope diameter and to removably
house a plurality of B-form staples, at least one of the plurality
of B-form staples having a base length and a leg length, the leg
length at least 53% of the envelope diameter; a first slot shaped
to receive a translating cutting mechanism; a second slot shaped to
house at least a first one of the plurality of staples; and a third
slot shaped to house at least a second one of the plurality of
staples at an angle oblique to the first one of the plurality of
staples.
Example 2
[0146] The cartridge of example 1, further comprising: a curved
tissue clamping interface; and wherein the oblique angle is between
about 4 degrees and about 30 degrees.
Example 3
[0147] The cartridge of example 1 or example 2, wherein: the second
slot is shaped to translatably house at least a first staple
pusher; the third slot is shaped to translatably house at least a
second staple pusher; and the second slot and the third slot are
configured to limit the first staple pusher to translation at an
angle oblique to translation of the second staple pusher.
Example 4
[0148] The cartridge of example 1, wherein: the second slot is
shaped to translatably house at least a first staple pusher shaped
to support at least the first one of the plurality of staples and a
third one of the plurality of staples parallel to the first one of
the plurality of staples; the third slot is shaped to translatably
house at least a second staple pusher oblique to the first staple
pusher, the second staple pusher shaped to support at least the
second one of the plurality of staples and a fourth one of the
plurality of staples parallel to the second one of the plurality of
staples.
Example 5
[0149] The cartridge of example any one of the preceding examples,
wherein one of: at least one of the plurality of staples has a leg
length of 3.42 mm or greater, and the envelope diameter is 5.6 mm
or less; or at least one of the plurality of staples has a nominal
leg length of 4.72 mm or greater, and the envelope diameter is 8.6
mm or less.
Example 6
[0150] The cartridge of example 3 or example 4, wherein: the second
slot is shaped to slidably receive a first longitudinally
translating cam to effectuate a sliding motion of the first staple
pusher; and the third slot is shaped to slidably receive a second
longitudinally translating cam to effectuate a sliding motion of
the second staple pusher oblique to the sliding motion of the first
staple pusher.
Example 7
[0151] The cartridge of any one of the preceding examples, wherein
the cartridge comprises a curved tissue clamping interface; and the
cartridge is configured to position at least one of the plurality
of staples at an angle normal to the curved tissue clamping
interface.
Example 8
[0152] The cartridge of example 7, wherein: the curved tissue
clamping interface is curved about a longitudinal axis extending
between a proximal end and a distal end of the elongated body; and
the curved tissue clamping interface has a radius of between 40%
and 60% of the envelope diameter.
Example 9
[0153] The cartridge of example 8, wherein: the envelope diameter
is 5.6 mm or less; and at least one of at least the first one of
the plurality of staples has a leg length of 3.42 mm or greater; or
at least the first one of the plurality of staples is configured to
form about tissue clamped to a thickness greater than 1.5 mm.
Example 10
[0154] The cartridge of example 1, wherein one of: at least the
first one of the plurality of staples has a leg length of 3.42 mm
or greater, and the envelope diameter is 5.6 mm or less; or at
least the first one of the plurality of staples has a leg length of
4.72 mm or greater, and the envelope diameter is 8.6 mm or
less.
Example 11
[0155] The cartridge of any one of the preceding examples,
wherein:
[0156] at least the first one of the plurality of staples is
configured to staple about tissue clamped up to a tissue thickness;
and the tissue thickness is at least 20% of the envelope
diameter.
Example 12
[0157] The cartridge of example 11, wherein: the tissue thickness
is between about 22% and about 36% of the envelope diameter.
Example 13
[0158] The cartridge of example 1, further comprising: a recess for
coupling to a cartridge support jaw; and wherein one of the
cartridge and the support jaw are shaped to fit within an envelope
diameter of 5.6 mm or less; or the cartridge and the support jaw
are shaped to fit within an envelope diameter of 8.6 mm or
less.
Example 14
[0159] The cartridge of example 1, further comprising: a curved
tissue clamping interface.
Example 15
[0160] The cartridge of any one of the preceding examples, wherein:
at least one of the plurality of staples has a leg length that is
at least 61% of the envelope diameter.
Example 16
[0161] A surgical stapler, comprising: an anvil movably coupled to
a support jaw between a clamped configuration wherein the anvil and
the support jaw are configured to clamp tissue positioned
therebetween, and a closed configuration wherein a tissue clamping
interface in the anvil abuts a tissue clamping interface in the
cartridge; wherein the support jaw comprises a cartridge having an
elongated body configured to removably house a plurality of B-form
staples, at least one of the plurality of B-form staples having a
base length and a leg length, the cartridge further comprising a
first slot shaped to receive a translating cutting mechanism, a
second slot shaped to house at least a first one of the plurality
of staples, and a third slot shaped to house at least a second one
of the plurality of staples at an angle oblique to the first one of
the plurality of staples; the anvil and the support jaw comprising
the cartridge are shaped to fit within an envelope diameter when in
the closed configuration; and the leg length of the at least one of
the plurality of B-form staples is at least 53% of the envelope
diameter.
Example 17
[0162] The stapler of example 16, wherein: the third slot is shaped
to house the second one of the plurality of staples at an angle of
between about 4 degrees and about 30 degrees relative to the first
one of the plurality of staples.
Example 18
[0163] The stapler of example 16 or example 17, wherein: the second
slot is shaped to translatably house at least a first staple
pusher; the third slot is shaped to translatably house at least a
second staple pusher; and the second slot and the third slot are
configured to limit the first staple pusher to translation at an
angle oblique to translation of the second staple pusher.
Example 19
[0164] The stapler of example 16, wherein: the second slot is
shaped to translatably house at least a first staple pusher shaped
to support at least the first one of the plurality of staples and a
third one of the plurality of staples parallel to the first one of
the plurality of staples; the third slot is shaped to translatably
house at least a second staple pusher oblique to the first staple
pusher, the second staple pusher shaped to support at least the
second one of the plurality of staples and a fourth one of the
plurality of staples.
Example 20
[0165] The stapler of any one of examples 16-19, wherein one of: at
least one of the plurality of staples has a leg length of 3.42 mm
or greater, and the envelope diameter is 5.6 mm or less; or at
least one of the plurality of staples has a leg length of 4.72 mm
or greater, and the envelope diameter is 8.6 mm or less; or the
envelope diameter is 5.6 mm or less, and the stapler is configured
to staple and cut tissue resulting in a cuff width of greater than
0.5 mm.
Example 21
[0166] The stapler of example 19, further comprising: a first
longitudinally translating cam; a second longitudinally translating
cam positioned oblique to the first longitudinally translating cam;
and wherein the second slot is shaped to slidably receive the first
longitudinally translating cam to effectuate a sliding motion of
the first staple pusher; and the third slot is shaped to slidably
receive the second longitudinally translating cam to effectuate a
sliding motion of the second staple pusher oblique to the sliding
motion of the first staple pusher.
Example 22
[0167] The stapler of any one of examples 16-21, further
comprising: an expandable cutting mechanism configured to move
between a collapsed configuration wherein the cutting mechanism is
shaped to fit within the envelope diameter and an expanded
configuration wherein the cutting mechanism has a dimension that is
greater than the envelope diameter.
Example 23
[0168] The stapler of examples 16-21, further comprising: an
expandable cutting mechanism having a first member with a cutting
portion and a second member; wherein the cutting mechanism is
configured to move between a collapsed configuration wherein the
cutting portion does not intersect a longitudinal axis defined by
the tissue clamping interface of the cartridge and an expanded
configuration wherein the cutting portion intersects the
longitudinal axis defined by the tissue clamping interface of the
cartridge.
Example 24
[0169] The stapler of any one of examples 16-23, wherein one of: at
least the first one of the plurality of staples has a leg length of
3.42 mm or greater, and the envelope diameter is 5.6 mm or less; or
at least the first one of the plurality of staples has a leg length
of 4.72 mm or greater, and the envelope diameter is 8.6 mm or
less.
Example 25
[0170] The surgical stapler of example 16 or example 24, wherein:
the surgical stapler is configured to staple and cut tissue up to a
pre-defined tissue thickness; the tissue thickness is defined as a
distance between the anvil and the cartridge during stapling; and
the tissue thickness is at least 20% of the envelope diameter when
the stapler is in the closed configuration.
Example 26
[0171] The stapler of any one of examples 16-25, wherein: the anvil
has a curved tissue clamping interface; and the cartridge has a
curved tissue clamping interface shaped to engage the curved tissue
clamping interface of the anvil when the stapler is in the closed
configuration.
Example 27
[0172] The stapler of any one of examples 16-26, wherein: at least
one of the plurality of staples has a leg length that is at least
61% of the envelope diameter.
Example 28
[0173] A method of placing a surgical staple in a patient,
comprising: providing a surgical stapler in a closed configuration,
the stapler comprising an anvil movably coupled to a support jaw
between a clamped configuration wherein the anvil and the support
jaw are configured to clamp tissue positioned therebetween, and a
closed configuration wherein a tissue clamping interface in the
anvil abuts a tissue clamping interface in the cartridge, wherein
the support jaw comprises a cartridge configured to removably house
a plurality of B-form staples, at least one of the plurality of
B-form staples having a base length and a leg length, the cartridge
further comprising a first slot shaped to receive a translating
cutting mechanism, a second slot shaped to house at least a first
one of the plurality of staples, and a third slot shaped to house
at least a second one of the plurality of staples at an angle
oblique to the first one of the plurality of staples, the anvil and
the support jaw comprising the cartridge are shaped to fit within
an envelope diameter when in the closed configuration, and the leg
length of the at least one of the plurality of B-form staples is at
least 53% of the envelope diameter; passing at least a portion of
the stapler in the closed configuration through an envelope
diameter; positioning tissue between the anvil and the support jaw;
moving the anvil to the clamped configuration wherein the anvil and
the support jaw clamp the tissue; and causing the stapler to form
the plurality of staples about the tissue.
Example 29
[0174] The method of example 28, further comprising: housing a
third one of the plurality of staples parallel to the first one of
the plurality of staples; and housing a fourth one of the plurality
of staples parallel to the second one of the plurality of staples;
and wherein one of the surgical stapler has an envelope diameter of
5.6 mm or less; or the surgical stapler has an envelope diameter of
8.6 mm or less.
Example 30
[0175] The method of example 28, further comprising: clamping
tissue between a curved tissue clamping interface in the support
jaw and a curved tissue clamping interface in the anvil.
Example 31
[0176] A surgical stapler, comprising: an anvil movably coupled to
a support jaw between a clamped configuration wherein the anvil and
the support jaw are configured to clamp tissue positioned
therebetween, and a closed configuration wherein a tissue clamping
interface in the anvil abuts a tissue clamping interface in the
cartridge, the anvil and the support jaw defining an envelope
diameter when the anvil is in the closed configuration; and a
translating cutting mechanism having a first member having a
cutting portion, and a second member, the cutting mechanism movable
between a collapsed configuration wherein the cutting mechanism is
shaped to fit within the envelope diameter and an expanded
configuration wherein the cutting mechanism does not fit within the
envelope diameter; wherein the support jaw comprises a cartridge
having a first slot shaped to receive the translating cutting
mechanism, a second slot shaped to house at least a first one of
the plurality of staples, and a third slot shaped to house at least
a second one of the plurality of staples.
Example 32
[0177] The surgical stapler of example 31, wherein: at least one of
the first member or the second member has at least one guide, the
at least one guide configured to engage a corresponding guide on
the anvil to limit the cutting mechanism to translation relative to
the corresponding guide.
Example 33
[0178] The surgical stapler of example 31 or example 32, wherein
one of: the envelope diameter is 5.6 mm or less; or the envelope
diameter is 8.6 mm or less.
Example 34
[0179] The surgical stapler any one of examples 31-33, further
comprising: a first actuator coupled to the first member, the first
member configured to move the first member distally and onto the
anvil; and a second actuator coupled to the second member, the
actuator configured to move the second member distally and onto the
support jaw.
Example 35
[0180] The surgical stapler of example 34, wherein: the first
actuator comprises a flexible member.
Example 36
[0181] The surgical stapler of any one of examples 31-35, wherein:
the first member comprises at least one leg having a first flange;
and the second member comprises at least one leg having a second
flange, the first flange and the second flange shaped to limit
expansion of the cutting mechanism.
Example 37
[0182] The surgical stapler of any one of examples 31-36, wherein:
the cutting mechanism is configured to compress the anvil and the
support jaw towards each other and into the clamped configuration
as the cutting mechanism translates towards a distal end of the
surgical stapler.
Example 38
[0183] The surgical stapler of any one of examples 31-37, wherein:
the stapler has an envelope diameter of 5.6 mm in the closed
configuration, and is configured to staple and cut tissue clamped
between the anvil and the support jaw such that the cut tissue has
a cuff width of greater than 0.5 mm.
[0184] Each of the various elements disclosed herein may be
achieved in a variety of manners. This disclosure should be
understood to encompass each such variation, be it a variation of
an embodiment of any apparatus embodiment, a method or process
embodiment, or even merely a variation of any element of these.
Particularly, it should be understood that the words for each
element may be expressed by equivalent apparatus terms or method
terms--even if only the function or result is the same. Such
equivalent, broader, or even more generic terms should be
considered to be encompassed in the description of each element or
action. Such terms can be substituted where desired to make
explicit the implicitly broad coverage to which this invention is
entitled.
[0185] As but one example, it should be understood that all action
may be expressed as a means for taking that action or as an element
which causes that action. Similarly, each physical element
disclosed should be understood to encompass a disclosure of the
action which that physical element facilitates. Regarding this last
aspect, by way of example only, the disclosure of a clamp should be
understood to encompass disclosure of the act of clamping--whether
explicitly discussed or not--and, conversely, were there only
disclosure of the act of clamping, such a disclosure should be
understood to encompass disclosure of a "clamping mechanism". Such
changes and alternative terms are to be understood to be explicitly
included in the description.
[0186] The previous description of the disclosed embodiments is
provided to enable any person skilled in the art to make or use the
present invention. Various modifications to these embodiments will
be readily apparent to those skilled in the art, and the generic
principles defined herein may be applied to other embodiments
without departing from the spirit or scope of the invention. Thus,
the present invention is not intended to be limited to the
embodiments shown herein but is to be accorded the widest scope
consistent with the principles and novel features disclosed
herein.
* * * * *