U.S. patent application number 17/700599 was filed with the patent office on 2022-09-29 for systems and methods for preventing tissue migration in surgical staplers.
The applicant listed for this patent is Standard Bariatrics, Inc.. Invention is credited to Adam R. Dunki-Jacobs, Caleb J. Hayward, Saylan J. Lukas, Robert T. Means, III, Richard P. Nuchols, Mark S. Ortiz, Jonathan R. Thompson.
Application Number | 20220304765 17/700599 |
Document ID | / |
Family ID | 1000006588876 |
Filed Date | 2022-09-29 |
United States Patent
Application |
20220304765 |
Kind Code |
A1 |
Dunki-Jacobs; Adam R. ; et
al. |
September 29, 2022 |
SYSTEMS AND METHODS FOR PREVENTING TISSUE MIGRATION IN SURGICAL
STAPLERS
Abstract
A system for preventing unwanted tissue migration in surgical
staplers includes a surgical stapler having an end effector
including an upper jaw and a lower jaw. A distal end of the upper
jaw is connected to a distal end of the lower jaw, and a proximal
end of the upper jaw is connected to a proximal end of the lower
jaw. First and second tissue stops are formed on the distal and
proximal ends of the lower jaw, respectively. The second tissue
stop and the proximal end of the upper jaw define a no cut zone
when the surgical stapler is in an open position. The surgical
stapler also includes a tissue cutting device disposed within the
lower jaw for resecting tissue. The system also includes a warning,
blocking, impeding, or barrier forming device for preventing the
unwanted migration of tissue into the no tissue zone.
Inventors: |
Dunki-Jacobs; Adam R.;
(Cincinnati, OH) ; Ortiz; Mark S.; (Milford,
OH) ; Thompson; Jonathan R.; (Cincinnati, OH)
; Nuchols; Richard P.; (Williamsburg, OH) ;
Hayward; Caleb J.; (Goshen, OH) ; Means, III; Robert
T.; (Cincinnati, OH) ; Lukas; Saylan J.;
(Cincinnati, OH) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Standard Bariatrics, Inc. |
Cincinnati |
OH |
US |
|
|
Family ID: |
1000006588876 |
Appl. No.: |
17/700599 |
Filed: |
March 22, 2022 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
63164837 |
Mar 23, 2021 |
|
|
|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 2017/07257
20130101; A61B 90/03 20160201; A61B 2017/07285 20130101; A61B
17/07207 20130101; A61B 2017/07271 20130101; A61B 2090/036
20160201 |
International
Class: |
A61B 90/00 20060101
A61B090/00; A61B 17/072 20060101 A61B017/072 |
Claims
1. (canceled)
2. A system for preventing unwanted tissue migration in surgical
staplers, comprising: (a) a surgical stapler having an end effector
for dispensing surgical staples, wherein the end effector includes:
(i) an upper jaw the upper jaw including a proximal end and a
distal end; (ii) a lower jaw, the lower jaw including a proximal
end and a distal end, wherein the distal end of the upper jaw is
connected to the distal end of the lower jaw, and wherein the
proximal end of the upper jaw is connected to the proximal end of
the lower jaw; (iii) a first tissue stop formed on the distal end
of the lower jaw; (iv) a second tissue stop formed on the proximal
end of the of the lower jaw, wherein the second tissue stop and the
proximal end of the upper jaw define a no tissue zone when the
surgical stapler is in an open position; and (v) a tissue cutting
device disposed within the lower jaw for resecting tissue; and (b)
a warning, blocking, impeding, or barrier forming device for
preventing the unwanted migration of tissue into the no tissue zone
during surgical procedures such that resection of unstapled tissue
is prevented, wherein the warning, blocking, impeding, or barrier
forming device includes at least one warning label placed on the
surgical stapler for alerting a user of the surgical stapler to the
no tissue zone.
3. A system for preventing unwanted tissue migration in surgical
staplers, comprising: (a) a surgical stapler having an end effector
for dispensing surgical staples, wherein the end effector includes:
(i) an upper jaw the upper jaw including a proximal end and a
distal end; (ii) a lower jaw, the lower jaw including a proximal
end and a distal end, wherein the distal end of the upper jaw is
connected to the distal end of the lower jaw, and wherein the
proximal end of the upper jaw is connected to the proximal end of
the lower jaw; (iii) a first tissue stop formed on the distal end
of the lower jaw; (iv) a second tissue stop formed on the proximal
end of the of the lower jaw, wherein the second tissue stop and the
proximal end of the upper jaw define a no tissue zone when the
surgical stapler is in an open position; and (v) a tissue cutting
device disposed within the lower jaw for resecting tissue; and (b)
a warning, blocking, impeding, or barrier forming device for
preventing the unwanted migration of tissue into the no tissue zone
during surgical procedures such that resection of unstapled tissue
is prevented, wherein the warning, blocking, impeding, or barrier
forming device includes a flexible sheath, wherein the flexible
sheath is placed partially or completely around the proximal end of
the upper jaw and the proximal end of the lower jaw while
permitting opening and closing thereof.
4. The system of claim 2, wherein the warning, blocking, impeding,
or barrier forming device further includes a rigid shield, wherein
the rigid shield is formed on or attached to the proximal end of
the upper jaw.
5. The system of claim 2, wherein the warning, blocking, impeding,
or barrier forming device further includes a flexible band attached
to the upper jaw and to the lower jaw and extending therebetween,
and wherein at least a portion of the flexible band is located in
front of the second tissue stop.
6. A system for preventing unwanted tissue migration in surgical
staplers, comprising: (a) a surgical stapler having an end effector
for dispensing surgical staples, wherein the end effector includes:
(i) an upper jaw the upper jaw including a proximal end and a
distal end; (ii) a lower jaw, the lower jaw including a proximal
end and a distal end, wherein the distal end of the upper jaw is
connected to the distal end of the lower jaw, and wherein the
proximal end of the upper jaw is connected to the proximal end of
the lower jaw; (iii) a first tissue stop formed on the distal end
of the lower jaw; (iv) a second tissue stop formed on the proximal
end of the of the lower jaw, wherein the second tissue stop and the
proximal end of the upper jaw define a no tissue zone when the
surgical stapler is in an open position; and (v) a tissue cutting
device disposed within the lower jaw for resecting tissue; and (b)
a warning, blocking, impeding, or barrier forming device for
preventing the unwanted migration of tissue into the no tissue zone
during surgical procedures such that resection of unstapled tissue
is prevented, wherein the warning, blocking, impeding, or barrier
forming device includes a post extending between the upper jaw and
the lower jaw at a front end of the second tissue stop, wherein the
post either rotates or telescopes when the upper jaw and the lower
jaw open and close.
7. The system of claim 2, wherein the warning, blocking, impeding,
or barrier forming device further includes a curved or hinged
closure link extending between the proximal end of the upper jaw
and the proximal end of the lower jaw.
8. A system for preventing unwanted tissue migration in surgical
staplers, comprising: (a) a surgical stapler having an end effector
for dispensing surgical staples, wherein the end effector includes:
(i) an upper jaw the upper jaw including a proximal end and a
distal end; (ii) a lower jaw, the lower jaw including a proximal
end and a distal end, wherein the distal end of the upper jaw is
connected to the distal end of the lower jaw, and wherein the
proximal end of the upper jaw is connected to the proximal end of
the lower jaw; (iii) a first tissue stop formed on the distal end
of the lower jaw; (iv) a second tissue stop formed on the proximal
end of the of the lower jaw, wherein the second tissue stop and the
proximal end of the upper jaw define a no tissue zone when the
surgical stapler is in an open position; and (v) a tissue cutting
device disposed within the lower jaw for resecting tissue; and (b)
a warning, blocking, impeding, or barrier forming device for
preventing the unwanted migration of tissue into the no tissue zone
during surgical procedures such that resection of unstapled tissue
is prevented, wherein the warning, blocking, impeding, or barrier
forming device includes a sacrificial band of compliant material,
block of compliant material, or compliant balloon positioned
between the proximal end of the upper jaw and the proximal end of
the lower jaw.
9. A system for preventing unwanted tissue migration in surgical
staplers, comprising: (a) a surgical stapler having an end effector
for dispensing surgical staples, wherein the end effector includes:
(i) an upper jaw the upper jaw including a proximal end and a
distal end; (ii) a lower jaw, the lower jaw including a proximal
end and a distal end, wherein the distal end of the upper jaw is
connected to the distal end of the lower jaw, and wherein the
proximal end of the upper jaw is connected to the proximal end of
the lower jaw; (iii) a first tissue stop formed on the distal end
of the lower jaw; (iv) a second tissue stop formed on the proximal
end of the of the lower jaw, wherein the second tissue stop and the
proximal end of the upper jaw define a no tissue zone when the
surgical stapler is in an open position; and (v) a tissue cutting
device disposed within the lower jaw for resecting tissue; and (b)
a warning, blocking, impeding, or barrier forming device for
preventing the unwanted migration of tissue into the no tissue zone
during surgical procedures such that resection of unstapled tissue
is prevented, wherein the warning, blocking, impeding, or barrier
forming device includes a non-sacrificial block of rigid material
or piece of expandable material positioned between the proximal end
of the upper jaw and the proximal end of the lower jaw and adapted
to permit the tissue cutting device to pass therethrough.
10. (canceled)
11. The system of claim 13, wherein the mechanism disengages the
tissue cutting device before it reaches the no tissue zone.
12. A system for preventing unwanted tissue migration in surgical
staplers, comprising: (a) a surgical stapler having an end effector
for dispensing surgical staples, wherein the end effector includes:
(i) an upper jaw the upper jaw including a proximal end and a
distal end; (ii) a lower jaw, the lower jaw including a proximal
end and a distal end, wherein the distal end of the upper jaw is
connected to the distal end of the lower jaw, and wherein the
proximal end of the upper jaw is connected to the proximal end of
the lower jaw; (iii) a first tissue stop formed on the distal end
of the lower jaw; (iv) a second tissue stop formed on the proximal
end of the of the lower jaw, wherein the second tissue stop and the
proximal end of the upper jaw define a no tissue zone when the
surgical stapler is in an open position; and (v) a tissue cutting
device disposed within the lower jaw for resecting tissue; and (b)
a mechanism for preventing the unwanted migration of tissue into
the no tissue zone during surgical procedures such that resection
of unstapled tissue is prevented, wherein the mechanism stops the
tissue cutting device before it reaches the no tissue zone and
reverses its direction of travel toward the distal end of the lower
jaw.
13. A system for preventing unwanted tissue migration in surgical
staplers, comprising: (a) a surgical stapler having an end effector
for dispensing surgical staples, wherein the end effector includes:
an upper jaw the upper jaw including a proximal end and a distal
end; (ii) a lower jaw, the lower jaw including a proximal end and a
distal end, wherein the distal end of the upper jaw is connected to
the distal end of the lower jaw, and wherein the proximal end of
the upper jaw is connected to the proximal end of the lower jaw;
(iii) a first tissue stop formed on the distal end of the lower
jaw; (iv) a second tissue stop formed on the proximal end of the of
the lower jaw, wherein the second tissue stop and the proximal end
of the upper jaw define a no tissue zone when the surgical stapler
is in an open position; and (v) a tissue cutting device disposed
within the lower jaw for resecting tissue; and (b) a mechanism for
preventing the unwanted migration of tissue into the no tissue zone
during surgical procedures such that resection of unstapled tissue
is prevented, wherein the mechanism uses software or software and
sensors associated with operation of the surgical stapler for
detecting a presence of tissue within the no tissue zone and taking
corrective action.
14. The system of claim 13, further comprising audible, visual, or
tactile indicators, or combinations thereof, that are triggered by
the software or software and sensors when the presence of tissue is
detected within the no tissue zone.
15. A method for preventing unwanted tissue migration in a surgical
stapler having an end effector for dispensing surgical staples,
wherein the end effector includes an upper jaw having proximal end
and a distal end; a lower jaw having a proximal end and a distal
end, wherein the distal end of the upper jaw is connected to the
distal end of the lower jaw, and wherein the proximal end of the
upper jaw is connected to the proximal end of the lower jaw; a
first tissue stop formed on the distal end of the lower jaw; a
second tissue stop formed on the proximal end of the of the lower
jaw, wherein the second tissue stop and the proximal end of the
upper jaw define a no cut zone when the surgical stapler is in an
open position; and a tissue cutting device disposed within the
lower jaw for resecting tissue, the method comprising: providing a
warning, blocking, impeding, or barrier forming device for
preventing the unwanted migration of tissue into the no tissue zone
during surgical procedures such that resection of unstapled tissue
is prevented; or providing a mechanism for preventing the unwanted
migration of tissue into the no tissue zone during surgical
procedures such that resection of unstapled tissue is
prevented.
16. The method of claim 15, wherein the warning, blocking,
impeding, or barrier forming device includes at least one warning
label placed on the surgical stapler for alerting a user of the
surgical stapler to the no tissue zone.
17. The method of claim 15, wherein the warning, blocking,
impeding, or barrier forming device includes a flexible sheath,
wherein the flexible sheath is placed partially or completely
around the proximal end of the upper jaw and the proximal end of
the lower jaw while permitting opening and closing thereof.
18. The method of claim 15, wherein the warning, blocking,
impeding, or barrier forming device includes a rigid shield,
wherein the rigid shield is formed on or attached to the proximal
end of the upper jaw.
19. The method of claim 15, wherein the warning, blocking,
impeding, or barrier forming device includes a flexible band
attached to the upper jaw and to the lower jaw and extending
therebetween, and wherein at least a portion of the flexible band
is located in front of the second tissue stop.
20. The method of claim 15, wherein the warning, blocking,
impeding, or barrier forming device includes a post extending
between the upper jaw and the lower jaw at a front end of the
second tissue stop, wherein the post either rotates or telescopes
when the upper jaw and the lower jaw open and close.
21. The method of claim 15, wherein the warning, blocking,
impeding, or barrier forming device includes a curved or hinged
closure link extending between the proximal end of the upper jaw
and the proximal end of the lower jaw.
22. The method of claim 15, wherein the warning, blocking,
impeding, or barrier forming device includes a sacrificial band of
compliant material, block of compliant material, or compliant
balloon positioned between the proximal end of the upper jaw and
the proximal end of the lower jaw.
23. The method of claim 15, wherein the warning, blocking,
impeding, or barrier forming device includes a non-sacrificial
block of rigid material or piece of expandable material positioned
between the proximal end of the upper jaw and the proximal end of
the lower jaw and adapted to permit the tissue cutting device to
pass therethrough.
24. The method of claim 15, wherein the mechanism disengages the
tissue cutting device before it reaches the no tissue zone.
25. The method of claim 15, wherein the mechanism stops the tissue
cutting device before it reaches the no tissue zone and reverses
its direction of travel toward the distal end of the lower jaw.
26. The method of claim 15, wherein the mechanism uses software or
software and sensors associated with operation of the surgical
stapler for detecting a presence of tissue within the no tissue
zone and taking corrective action.
27. The method of claim 26, further comprising providing audible,
visual, or tactile indicators, or combinations thereof, that are
triggered by the software or software and sensors when the presence
of tissue is detected within the no tissue zone.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the priority benefit of U.S.
Provisional Patent Application No. 63/164,837, filed Mar. 23, 2021,
which is hereby incorporated herein by reference in its
entirety.
BACKGROUND
[0002] The disclosed inventive subject matter relates in general to
medical devices and surgical instruments and more specifically to
systems, devices, and methods associated with surgical staplers
used for bariatric surgery performed using laparoscopic
techniques.
[0003] Vertical sleeve gastrectomy is a commonly performed type of
bariatric surgery in which a surgical stapling instrument is used
to remove a portion of the stomach and staple the remaining portion
of the stomach closed. Stapling instruments used for this procedure
typically include an upper jaw that is connected to a lower jaw at
one end thereof using a hinge. Such devices usually include a
tissue stop at or near the hinge to prevent the undesirable
migration of tissue into the hinged region of the stapler during
use. More recently developed stapling instruments such as the
TITAN.RTM. SGS23R (Standard Bariatrics) and similar instruments
include an upper jaw that is connected to a lower jaw at two
locations, namely at both ends of the jaws. Staplers having this
design include a distal tissue stop and a proximal tissue stop
formed on the lower jaws thereof. However, when in the stapler is
in an open position, an area exists between the jaws adjacent to
the proximal tissue stop into which tissue may migrate during use
of the instrument. This migration may continue until a certain
degree of closure is reached, at which point the upper jaw engages
the proximal tissue stop of the lower jaw to create a tissue
barrier. If a surgeon inadvertently closes the stapler on stomach
tissue outside the portion of the instrument that ejects staples,
transection of tissue without mechanical fastening thereof with
staples may result. If this situation is not recognized by the
surgeon during the medical procedure, post-operative complications
such as leaks may occur. Because this is an undesirable outcome, an
additional barrier or other means of preventing tissue migration in
surgical stapling instruments would be beneficial.
SUMMARY
[0004] The following provides a summary of certain example
implementations of the disclosed inventive subject matter. This
summary is not an extensive overview and is not intended to
identify key or critical aspects or elements of the disclosed
inventive subject matter or to delineate its scope. However, it is
to be understood that the use of indefinite articles in the
language used to describe and claim the disclosed inventive subject
matter is not intended in any way to limit the described inventive
subject matter. Rather the use of "a" or "an" should be interpreted
to mean "at least one" or "one or more".
[0005] One implementation of the disclosed technology provides a
system for preventing unwanted tissue migration in surgical
staplers, comprising a surgical stapler having an end effector for
dispensing surgical staples, wherein the end effector includes an
upper jaw the upper jaw including a proximal end and a distal end;
a lower jaw, the lower jaw including a proximal end and a distal
end, wherein the distal end of the upper jaw is connected to the
distal end of the lower jaw, and wherein the proximal end of the
upper jaw is connected to the proximal end of the lower jaw; a
first tissue stop formed on the distal end of the lower jaw; a
second tissue stop formed on the proximal end of the of the lower
jaw, wherein the second tissue stop and the proximal end of the
upper jaw define a no tissue zone when the surgical stapler is in
an open position; and a tissue cutting device disposed within the
lower jaw for resecting tissue; and a warning, blocking, impeding,
or barrier forming device for preventing the unwanted migration of
tissue into the no tissue zone during surgical procedures such that
resection of unstapled tissue is prevented.
[0006] The warning, blocking, impeding, or barrier forming device
may include at least one warning label placed on the stapler for
alerting a user of the stapler to the no tissue zone. The warning,
blocking, impeding, or barrier forming device may include a
flexible sheath, wherein the flexible cape is placed partially or
completely around the proximal ends of the upper and lower jaws
while permitting the opening and closing thereof. The warning,
blocking, impeding, or barrier forming device may include a rigid
shield, wherein the rigid shield is formed on or attached to the
proximal end of the upper jaw. The warning, blocking, impeding, or
barrier forming device may include a flexible band attached to the
upper jaw and to the lower jaw and extending therebetween, and
wherein at least a portion of the flexible band is located in front
of the second tissue stop. The warning, blocking, impeding, or
barrier forming device may include a post extending between the
upper jaw and the lower jaw at the front end of the second tissue
stop, wherein the post either rotates or telescopes when the jaws
open and close. The warning, blocking, impeding, or barrier forming
device may include a curved or hinged closure link extending
between the proximal ends of the upper jaw and the lower jaw. The
warning, blocking, impeding, or barrier forming device may include
a sacrificial band of compliant material, block of compliant
material, or compliant balloon positioned between the proximal ends
of the upper jaw and the lower jaw. The warning, blocking,
impeding, or barrier forming device may include a non-sacrificial
block of rigid material or piece of expandable material positioned
between the proximal ends of the upper jaw and the lower jaw and
adapted to permit the tissue cutting device to pass
therethrough.
[0007] Another implementation of the disclosed technology provides
a system for preventing unwanted tissue migration in surgical
staplers, comprising a surgical stapler having an end effector for
dispensing surgical staples, wherein the end effector includes an
upper jaw the upper jaw including a proximal end and a distal end;
a lower jaw, the lower jaw including a proximal end and a distal
end, wherein the distal end of the upper jaw is connected to the
distal end of the lower jaw, and wherein the proximal end of the
upper jaw is connected to the proximal end of the lower jaw; a
first tissue stop formed on the distal end of the lower jaw; a
second tissue stop formed on the proximal end of the of the lower
jaw, wherein the second tissue stop and the proximal end of the
upper jaw define a no tissue zone when the surgical stapler is in
an open position; and a tissue cutting device disposed within the
lower jaw for resecting tissue; and a mechanism for preventing the
unwanted migration of tissue into the no tissue zone during
surgical procedures such that resection of unstapled tissue is
prevented.
[0008] The mechanism may disengage the tissue cutting device before
it reaches the no tissue zone. The mechanism may stop the tissue
cutting device before it reaches the no tissue zone and reverses
its direction of travel toward the distal end of the lower jaw. The
mechanism may use software or software and sensors associated with
the operation of the stapler for detecting the presence of tissue
within the no tissue zone and taking corrective action. The system
may also include audible, visual, or tactile indicators, or various
combinations thereof, that are triggered by the software or
software and sensors when the presence of tissue is detected within
the no tissue zone.
[0009] Another implementation of the disclosed technology provides
a method for preventing unwanted tissue migration in a surgical
stapler having an end effector for dispensing surgical staples,
wherein the end effector includes an upper jaw having proximal end
and a distal end; a lower jaw having a proximal end and a distal
end, wherein the distal end of the upper jaw is connected to the
distal end of the lower jaw, and wherein the proximal end of the
upper jaw is connected to the proximal end of the lower jaw; a
first tissue stop formed on the distal end of the lower jaw; a
second tissue stop formed on the proximal end of the of the lower
jaw, wherein the second tissue stop and the proximal end of the
upper jaw define a no tissue zone when the surgical stapler is in
an open position; and a tissue cutting device disposed within the
lower jaw for resecting tissue, the method comprising providing a
warning, blocking, impeding, or barrier forming device for
preventing the unwanted migration of tissue into the no tissue zone
during surgical procedures such that resection of unstapled tissue
is prevented; or providing a mechanism for preventing the unwanted
migration of tissue into the no tissue zone during surgical
procedures such that resection of unstapled tissue is
prevented.
[0010] The warning, blocking, impeding, or barrier forming device
may include at least one warning label placed on the stapler for
alerting a user of the stapler to the no tissue zone. The warning,
blocking, impeding, or barrier forming device may include a
flexible sheath, wherein the flexible cape is placed partially or
completely around the proximal ends of the upper and lower jaws
while permitting the opening and closing thereof. The warning,
blocking, impeding, or barrier forming device may include a rigid
shield, wherein the rigid shield is formed on or attached to the
proximal end of the upper jaw. The warning, blocking, impeding, or
barrier forming device may include a flexible band attached to the
upper jaw and to the lower jaw and extending therebetween, and
wherein at least a portion of the flexible band is located in front
of the second tissue stop. The warning, blocking, impeding, or
barrier forming device may include a post extending between the
upper jaw and the lower jaw at the front end of the second tissue
stop, wherein the post either rotates or telescopes when the jaws
open and close. The warning, blocking, impeding, or barrier forming
device may include a curved or hinged closure link extending
between the proximal ends of the upper jaw and the lower jaw. The
warning, blocking, impeding, or barrier forming device may include
a sacrificial band of compliant material, block of compliant
material, or compliant balloon positioned between the proximal ends
of the upper jaw and the lower jaw. The warning, blocking,
impeding, or barrier forming device may include a non-sacrificial
block of rigid material or piece of expandable material positioned
between the proximal ends of the upper jaw and the lower jaw and
adapted to permit the tissue cutting device to pass therethrough.
The mechanism may disengage the tissue cutting device before it
reaches the no tissue zone. The mechanism may stop the tissue
cutting device before it reaches the no tissue zone and reverses
its direction of travel toward the distal end of the lower jaw. The
mechanism may use software or software and sensors associated with
the operation of the stapler for detecting the presence of tissue
within the no tissue zone and taking corrective action Audible,
visual, or tactile indicators, or various combinations thereof,
that are triggered by the software or software and sensors when the
presence of tissue is detected within the no tissue zone, may also
be provided.
[0011] It should be appreciated that all combinations of the
foregoing concepts and additional concepts discussed in greater
detail below (provided such concepts are not mutually inconsistent)
are contemplated as being part of the inventive subject matter
disclosed herein and may be implemented to achieve the benefits as
described herein. Additional features and aspects of the disclosed
system, devices, and methods will become apparent to those of
ordinary skill in the art upon reading and understanding the
following detailed description of the example implementations. As
will be appreciated by the skilled artisan, further implementations
are possible without departing from the scope and spirit of what is
disclosed herein. Accordingly, the drawings and associated
descriptions are to be regarded as illustrative and not restrictive
in nature.
BRIEF DESCRIPTION OF THE DRAWINGS
[0012] The accompanying drawings, which are incorporated into and
form a part of the specification, schematically illustrate one or
more example implementations of the disclosed inventive subject
matter and, together with the general description given above and
detailed description given below, serve to explain the principles
of the disclosed subject matter, and wherein:
[0013] FIGS. 1A and 1B depict, in an exploded view and a
perspective view, respectively, an example surgical stapler that is
hinged at two locations along the length of the stapler and that
includes a no tissue zone into which tissue may unwantedly migrate
during surgical procedures such as laparoscopic bariatric
surgery;
[0014] FIG. 2 depicts the surgical stapler of FIG. 1A, wherein a
physical label has been placed on the lower jaw of the stapler
indicating that "no tissue" is to be situated within the labeled
region;
[0015] FIG. 3 depicts the stapler of FIG. 1A, wherein the jaws of
the stapler are shown in a closed position and wherein a flexible
tissue-blocking sheath has been partially wrapped around the upper
and lower jaws of the stapler;
[0016] FIG. 4 depicts the stapler of FIG. 1A, wherein the jaws of
the stapler are shown in an open position and wherein a flexible
tissue-blocking sheath has been partially wrapped around the upper
and lower jaws of the stapler;
[0017] FIG. 5 depicts the stapler of FIG. 1A, wherein the jaws of
the stapler are shown in a closed position and wherein a flexible
tissue-blocking sleeve has been circumferentially wrapped around
the upper and lower jaws of the stapler;
[0018] FIG. 6 depicts the stapler of FIG. 1A, wherein the jaws of
the stapler are shown in an open position and wherein a flexible
tissue-blocking sleeve has been circumferentially wrapped around
the upper and lower jaws of the stapler;
[0019] FIG. 7 depicts the stapler of FIG. 1A, wherein the jaws of
the stapler are shown in an open position and wherein a flexible,
braided, tissue-blocking sleeve has been circumferentially wrapped
around the upper and lower jaws of the stapler
[0020] FIG. 8 depicts the upper jaw of the stapler of FIG. 1A,
wherein a recessed region has been formed therein for accommodating
a flexible sheath or sleeve;
[0021] FIG. 9 depicts the stapler of FIG. 1A in a closed position,
wherein the tissue cutting knife, also referred to as an I-beam or
I-shaped blade, is visible near the distal pin;
[0022] FIG. 10 depicts a mechanical method for stopping the I-Beam
from crashing into the distal pin when reversing the knife, wherein
the threads on the firing lead screw stop distally, passively
limiting the reverse travel of the firing nut;
[0023] FIG. 11 depicts a mechanical method for stopping the I-Beam
from striking the distal pin when reversing the knife, where the
threads on the firing lead screw stop distally, passively limiting
the reverse travel of the firing nut, but where the firing screw
compression spring is mobile rather than fixed;
[0024] FIG. 12 depicts the stapler of FIG. 1A, where the jaws of
the stapler are shown in a closed position and where a
tissue-blocking anvil cap has been formed or placed on the upper
jaw of the stapler;
[0025] FIG. 13 depicts the stapler of FIG. 1A, where the jaws of
the stapler are shown in an open position and wherein a
tissue-blocking anvil cap has been formed or placed on the upper
jaw of the stapler;
[0026] FIG. 14 depicts an implementation that prevents the
transection of tissue without closure thereof with surgical staples
through the use of a cantilever beam;
[0027] FIG. 15 depicts an implementation that utilizes a reversing
knife approach to preventing the transection of tissue without
closure thereof with surgical staples through the inclusion of a
secondary thread on the primary firing screw;
[0028] FIG. 16 depicts an implementation that utilizes a reversing
knife approach to preventing the transection of tissue without the
closure thereof with surgical staples through the inclusion of a
secondary fine thread on an auxiliary firing screw;
[0029] FIG. 17 depicts the stapler of FIG. 1A, where the jaws of
the stapler are shown in an open position and where a
tissue-blocking elastomeric band has been mounted on an attachment
screw on the upper jaw and an attachment screw on the lower
jaw;
[0030] FIG. 18 depicts the stapler of FIG. 1A, wherein the jaws of
the stapler are shown in an open position and wherein a
tissue-blocking elastomeric band has been mounted on two attachment
screws on the upper jaw and two attachment screws on the lower jaw
in a crossed configuration;
[0031] FIG. 19 depicts the stapler of FIG. 1A, wherein the jaws of
the stapler are shown in an open position and wherein a
tissue-blocking elastomeric band has been mounted an attachment
screw on the upper jaw and two attachment screws on the lower jaw
in a triangular configuration;
[0032] FIG. 20 depicts the stapler of FIG. 1A, wherein the jaws of
the stapler are shown in an open position and wherein a
tissue-blocking rotating post has been positioned between the upper
and lower jaws of the stapler;
[0033] FIG. 21 depicts the stapler of FIG. 1A, wherein the jaws of
the stapler are shown in an open position and where a
tissue-blocking telescoping post has been positioned between the
upper and lower jaws of the stapler;
[0034] FIG. 22 depicts the stapler of FIG. 1A, wherein the jaws of
the stapler are shown in an open position and where a
tissue-blocking curved linkage has been positioned between the
upper and lower jaws of the stapler;
[0035] FIG. 23 depicts the stapler of FIG. 1A, wherein the jaws of
the stapler are shown in an open position and where a
tissue-blocking passive curved linkage has been positioned between
the upper and lower jaws of the stapler;
[0036] FIG. 24 depicts the stapler of FIG. 1A, wherein the jaws of
the stapler are shown in an open position and where a
tissue-blocking pivoting double linkage has been positioned between
the upper and lower jaws of the stapler;
[0037] FIG. 25 depicts the stapler of FIG. 1A, wherein the jaws of
the stapler are shown in an open position and where a
tissue-blocking sacrificial cut band has been positioned between
the upper and lower jaws of the stapler;
[0038] FIG. 26 depicts the stapler of FIG. 1A, wherein the jaws of
the stapler are shown in an open position and wherein a
tissue-blocking split band has been positioned between the upper
and lower jaws of the stapler;
[0039] FIG. 27 depicts the stapler of FIG. 1A, wherein the jaws of
the stapler are shown in an open position and wherein a
tissue-blocking compliant sacrificial foam block has been
positioned between the upper and lower jaws of the stapler;
[0040] FIG. 28 depicts the stapler of FIG. 1A, wherein the jaws of
the stapler are shown in an open position and wherein a
tissue-blocking compliant sacrificial balloon has been positioned
between the upper and lower jaws of the stapler;
[0041] FIG. 29 depicts the stapler of FIG. 1A, wherein the jaws of
the stapler are shown in an open position and wherein a
zero-clearance block has been positioned between the upper and
lower jaws of the stapler;
[0042] FIG. 30 depicts the stapler of FIG. 1A, wherein the jaws of
the stapler are shown in an open position and wherein an
accordion-like tissue blocking device has been positioned between
the upper and lower jaws of the stapler;
[0043] FIG. 31 depicts the stapler of FIG. 1A, wherein the jaws of
the stapler are shown in an open position and wherein an alternate
accordion-like tissue blocking device has been positioned between
the upper and lower jaws of the stapler;
[0044] FIG. 32 depicts an implementation that utilizes disengaging
I-beam knife approach (normal orientation) to prevent the
transection of tissue without the closure thereof with surgical
staples;
[0045] FIG. 33 depicts an implementation that utilizes a
disengaging I-beam knife approach, shown in a disengaged
orientation, to prevent the transection of tissue without the
closure thereof with surgical staples; and
[0046] FIG. 34 depicts an implementation that utilizes an external
device or introducer sheath to shield a no tissue zone.
DETAILED DESCRIPTION
[0047] Example implementations are now described with reference to
the Figures. Reference numerals are used throughout the detailed
description to refer to the various elements and structures.
Although the following detailed description contains many specifics
for the purposes of illustration, a person of ordinary skill in the
art will appreciate that many variations and alterations to the
following details are within the scope of the disclosed inventive
subject matter. Accordingly, the following implementations are set
forth without any loss of generality to, and without imposing
limitations upon, the claimed subject matter.
[0048] As previously stated, surgical stapling instruments such as
the TITAN.RTM. SGS23R (Standard Bariatrics) include an upper jaw
that is connected to a lower jaw at two locations, namely at both
ends of the jaws. Staplers having this design can include a distal
tissue stop and a proximal tissue stop formed on the lower jaws
thereof. However, when the stapler is in an open position, an area
may exist between the jaws adjacent to the proximal tissue stop
into which tissue may migrate during use of the instrument. This
migration may be problematic if a surgeon inadvertently closes the
stapler on stomach tissue that has migrated outside the portion of
the instrument that ejects and secures tissue with staples. In such
an area, where tissue has not been stapled, transection of tissue
may still progress resulting in a potentially dangerous unstapled
portion of the transected tissue. If this situation is not
recognized by the surgeon during the medical procedure,
post-operative complications such as leaks may occur. Disclosed
implementations provide various structural and mechanical systems,
devices, and methods for preventing the unwanted migration of
tissue when staplers such as the TITAN.RTM. SGS23R are used in
laparoscopic bariatric surgery.
[0049] Staplers compatible with the disclosed technology are
described in U.S. Pat. No. 10,687,814, which is incorporated by
reference herein in its entirety, for all purposes. Some
implementations of the staplers disclosed in U.S. Pat. No.
10,687,814 include end effectors that are attached to a support
tube that is attached to a handle that includes an actuator for the
instrument. As shown in the Figures of U.S. Pat. No. 10,687,814,
example end effectors found on surgical staplers include an upper
jaw connected to a lower jaw by a simple hinge at the distal end of
the stapler and by a master link or rigid link at the proximal end
of the stapler. The upper jaw may include an anvil assembly that
further includes an anvil frame, an anvil plate, and an anvil plate
channel formed therein. The lower jaw may include a cartridge
assembly that further includes a cartridge frame, a cartridge plate
with a cartridge plate channel formed therein, and a cartridge for
containing surgical staples. The cartridge frame may include a
first tissue stop and a second tissue stop as well as first and
second cartridge pins. A blade assembly that includes a cutting
blade is disposed within the cartridge assembly. The master link
may include a master link pin that cooperates with a master link
slot.
[0050] FIGS. 1A-1B depict example surgical stapler having end
effector 100 (e.g., TITAN.RTM. SGS23R), which includes upper jaw
120, lower jaw 140, blade/knife assembly 170, and master link 180.
Upper jaw 120 includes anvil assembly 122, which further includes
anvil frame 124, anvil plate 126, and anvil plate channel 128.
Lower jaw 140 includes cartridge assembly 142, which further
includes cartridge frame 144, cartridge plate 146, cartridge 150,
distal tissue stop 152, proximal tissue stop 154, distal cartridge
pin 156, and proximal cartridge pin 158. Distal cartridge pin 156
connects upper jaw 120 and lower jaw 140 in a hinged manner at the
distal end of end effector 100. Blade/knife assembly 170, which
includes I-beam or I-shaped knife 172 (see also FIG. 9) is disposed
within lower jaw 140. Master link 180 connects upper jaw 120 and
lower jaw 140 at the proximal end of end effector 100 in a hinged
manner using master pin 182, which is positioned in a sliding
manner within master link slot 184. End effector 100 is attached to
elongated support tube 190, which is connected to handle 200 (see
also FIGS. 5 and 6). Handle 200 includes various mechanical aspects
that actuate end effector 100 and knife 172. A region of concern or
"no tissue zone" 160 can be any area or space into which tissue may
unwantedly migrate during surgical procedures such as laparoscopic
bariatric surgery. No tissue zone 160 may be located at the
proximal end of the end effector, for example, but may be any area
where tissue migration is problematic.
[0051] FIG. 2 depicts an example labeling solution to the tissue
migration concern. FIG. 2 depicts the surgical stapler of FIG. 1B,
wherein a physical label has been placed on the lower jaw of end
effector 100 indicating that "no tissue" is to be situated within
the labeled region, which is no tissue zone 160). "No tissue"
graphics may also be included on top of anvil assembly 122, on
upper jaw 120, on the side of cartridge assembly 142, on lower jaw
140, or on any other surface of end effector 100 to alert the user
of the risk. Labeling may be affixed to end effector 100 using
adhesive, or by screen printing, laser etching, or the like, and
may include additional or alternate phrases, as wells as various
fonts, colors, and graphics intended to draw the attention of a
user to the no tissue zone.
[0052] FIGS. 3-8 depict various implementations of a
tissue-blocking shield placed around the jaws of end effector 100
for the purpose preventing tissue from migrating into region 160
while still permitting the jaws of end effector 100 to open. FIG. 3
depicts the stapler of FIG. 1B, wherein the jaws of end effector
100 are shown in a closed position and flexible tissue-blocking
sheath 300 has been partially wrapped around upper and lower jaws
120 and 140 of end effector 100. FIG. 4 depicts the stapler of FIG.
1B, where the jaws of end effector 100 are shown in an open
position and flexible tissue-blocking elastomeric sheath 300 has
been partially wrapped around upper and lower jaws 120 and 140 of
end effector 100. Sheath lock 302 is included in this
implementation for locking cape 300 on end effector 100. Sheath
lock 302 may be an overmolded plastic component located on either
side of lower jaw 140. Sheath lock 302 may be affixed to lower jaw
140 with a screw or other positive fixation device such as a rivet,
pin, orbital rivet, or heat stake. The proximal end of sheath lock
302 is affixed to lower jaw 140 by engaging an interlocking feature
in support tube 190. Sheath lock 302 may incorporate a jaw lock
component or may engage with a jaw lock to constrain the sheath
lock FIG. 5 depicts the end effector of FIG. 1B, where the jaws of
end effector 100 are shown in a closed position and elastomeric
tissue-blocking sleeve 310 has been circumferentially wrapped
around upper and lower jaws 120 and 140 of end effector 100. FIG. 6
depicts the end effector of FIG. 1B, where the jaws of end effector
100 are shown in an open position and elastomeric tissue-blocking
sleeve 310 has been circumferentially wrapped around upper and
lower jaws 120 and 140 of end effector 100. FIG. 7 depicts the end
effector of FIG. 1B, wherein the jaws of end effector 100 are shown
in an open position and flexible, braided mesh barrier 320 has been
circumferentially wrapped around upper and lower jaws 120 and 140
of end effector 100. FIG. 8 depicts upper jaw 120 of the end
effector of FIG. 1B, wherein recessed region 322 has been formed
therein for accommodating a flexible cape or sleeve.
[0053] The sheath and sleeve described above may be made from a
variety of elastic materials including silicone, urethane, or the
like, or may be geometrically flexible such as the braided
implementation of FIG. 7. The implementation shown in FIG. 7 may
include bands placed on both ends of the sleeve to prevent the
sleeve from fraying. Alternately, both ends of the sleeve may be
overmolded with an elastomeric material to prevent the sleeve from
fraying. The sheath and sleeve may be lubricated to minimize drag
force when inserting the stapling instrument into a trocar.
Lubrication may be achieved by altering the surface finish of the
sheath, adding a lubricant to the sheath such as a silicone grease,
polytetrafluoroethylene (PTFE) solids or the like, or by doping the
sheath material with a lubricant. Adding a stainless steel or
plastic spine (not shown) to the top of the sheath may also reduce
drag force. The spine may be over-molded to the sheath or rigidly
attached to anvil frame 124 by the use of screws or snaps, or by
welding, gluing, or other process. Sheath lock 302 member fixes
sheath 300 to end effector 100 and may be made of a metal such as
stainless steel, or a plastic such as nylon, and may be attached to
cartridge frame 144 by a screws, snaps, or other devices. Sheath
300 and sheath lock 302 may be separate components or a single
component installed on end effector 100 by over-molding sheath 300
to sheath lock 302. Sheath lock 302 may incorporate a jaw lock
component or may engage with a jaw lock to constrain the sheath
lock. The previously described no tissue zone labeling may be
included on some or all variants of sheath 300.
[0054] FIG. 9 depicts end effector 100 in a closed position where
tissue cutting knife 172, also referred to as an I-beam or I-shaped
blade, is visible near distal pin 156. Regarding FIG. 9, one
implementation of the disclosed technology provides a reversing
knife solution to the previously discussed tissue migration
concern. This approach eliminates the problem of transecting
unstapled tissue by stopping knife 172 before it reaches the no
tissue zone at the proximal end of the end effector 100. After
transecting only stapled portions of tissue, the knife 172 can be
distally to its starting position, tangent to distal pin 156, as
shown in FIG. 9. Using this method, knife 172 will not cut tissue
without also firing staples along the cut line.
[0055] The solution reversing the knife 172, as described above,
may be accomplished using software included with commercially
available stapling instruments such as, for example, the TITAN.RTM.
SGS23R "Standard Power Unit" (SPU) software. Once a knife band (see
U.S. Pat. No. 10,687,814) activates a limit switch at the proximal
limit of firing, such as at the proximal end of the end effector
100, the SPU software can reverse the polarity of the firing motor,
to reverse the direction of the knife band. To stop the I-Beam from
striking the distal pin 156 when reversing the knife, the SPU can
actively monitor the presence of the I-Beam at the distal tip of
the end effector 100. A distal limit switch may be attached to end
effector 100, stopping the firing motor when the I-Beam has reached
its distal position (see FIG. 9). The distal limit switch may be a
digital switch that operates in a binary on/off nature depending on
whether the I-Beam is at its distal position or not, or an analog
sensor that provides a range of values depending on where the
I-Beam is located in the firing stroke. If the switch is binary, it
may be an off-the-shelf (OTS) single pole single throw (SPST) limit
switch that is mounted to a printed circuit board (PCB), a
stand-alone OTS limit switch wired back to the SPU by way of a
power cable, or a custom limit switch consisting of a movable
component that electrically connects (normally open, "NO") or
disconnects (normally closed, "NC"), two terminals connected to the
SPU. In one implementation, the I-Beam and distal pin 156 cooperate
to complete an electric connection and act as a binary switch. If
the switch is analog, it may be an OTS analog sensor that is
mounted to a PCB or a stand-alone OTS limit switch wired back to
the SPU by way of a power cable such as a proximity sensor,
ultrasonic sensor, time of light sensor (ToF), laser sensor, light
detecting and ranging (LIDAR) sensor, or the like, or a custom
analog sensor connected to the SPU. Some implementations include
various indicators such as, for example, audible, visual, or
tactile indicators, or combinations thereof, that are triggered by
the software and sensors when the presence of tissue is detected
within no tissue zone 160.
[0056] In some implementations, a rotary encoder is included with
the firing motor to stop the I-Beam from crashing into distal pin
156 when reversing knife 172, to provide closed-loop feedback of
the motor's rotary position. With an encoder, the SPU software
monitors the number of motor turns required to activate the
proximal firing limit switch and repeats the same number of motor
turns to return the knife band to its starting position. Suitable
motor encoder technology may be mechanical, optical, or magnetic
(hall-effect) to track the rotation of the motor shaft. The SPU may
also monitor real-time electrical motor current in amperes to
compare to preset current limits when using a device such as the
TITAN.RTM. SGS23R. The current limits may mitigate damage to the
device when in use. The SPU may further monitor the firing motor
current when reversing the knife, monitoring for a current spike
above a preset threshold to determine when the I-Beam contacts
distal pin 156. System software may, for example, only monitor for
the current spike at a percentage of the return sequence by means
of time or using an encoder as described above. In a similar
manner, in an alternate implementation, the SPU monitors the
closure motor current for the presence of tissue in the no tissue
zone. Tissue in the no tissue zone induces a spike in current on
the closure motor within a fixed window of time or closure stroke.
Identifying this minimum current spike allows the SPU to detect
tissue in the no tissue zone and warn the user of imminent tissue
damage and/or prevent the user from firing the device.
[0057] FIG. 10 depicts another implementation for stopping the
I-Beam from striking distal pin 156 when reversing knife 172,
wherein the threads on firing lead screw 402 stop distally,
passively limiting the reverse travel of firing nut 406. In this
implementation, firing nut 406 exhausts the threads on firing lead
screw 402 and slips on the threads as firing lead screw 402
continues to turn to drive firing nut 406 distally. Fixed firing
screw compression spring 410 applies a load proximally on firing
nut 406 and allows firing nut 406 to reengage with firing lead
screw 402 when firing lead screw 402 rotates to drive firing nut
406 proximally. Fixed firing lead screw 402 is constrained
laterally by firing bushing 412 and the threads of firing lead
screw 402, limited by its inner diameter (ID) being less than the
major diameter of the threads of firing lead screw 402.
[0058] FIG. 11 depicts another implementation for stopping the
I-Beam from crashing into distal pin 156 when reversing knife 172,
wherein the threads on firing screw 402 stop distally, passively
limiting the reverse travel of firing nut 406, but where firing
screw compression spring 410 is mobile rather than fixed. In this
implementation, mobile firing screw compression spring 410 is
constrained by nut plate 414 and firing nut 406, and spring 410
travels along the threaded and unthreaded portion of firing lead
screw 402 as firing nut 406 and nut plate 414 travel. Nut plate 414
is unthreaded, unlike firing nut 406, and slides along the threaded
and unthreaded portion of firing lead screw 402 like mobile firing
screw compression spring 410. When firing nut 406 exhausts the
threads on firing lead screw 402, it will slip on the threads as
firing lead screw 402 continues to turn to drive firing nut 406
distally. Unlike the previous implementation, this variant
anticipates a crash of the I-Beam and distal pin 156, but mobile
firing screw compression spring 410 provides a compliant power
transfer from firing nut 406 and knife band 408 when firing nut 406
is driven distally.
[0059] FIG. 12 depicts end effector 100, wherein the jaws of end
effector 100 are shown in a closed position and wherein
tissue-blocking anvil cap 330 has been formed or placed on upper
jaw 120 of end effector 100. FIG. 13 depicts end effector 100,
wherein the jaws of end effector 100 are shown in an open position
and wherein tissue-blocking anvil cap 330 has been formed or placed
on upper jaw 120 of end effector 100. In this implementation, anvil
cap 300 may be formed on anvil frame 124 or may be rigidly attached
thereto as a separate structure using welding, adhesives, or
attachment hardware such as bolts or screws. Anvil cap 330
cooperates with second proximal tissue stop 154 on cartridge frame
144 to create a shield for preventing tissue from entering no
tissue zone 160. When upper and lower jaws 120 and 140 are closed,
anvil cap 330 may not protrude past the bottom edge of cartridge
frame 144. When upper and lower jaws 120 and 140 are open, anvil
cap 330 can shield the no tissue zone.
[0060] FIG. 14 depicts an implementation that prevents the
transection of unstapled tissue. This implementation is referred to
as the "cantilever beam" and includes disengaging I-beam knife 172.
In FIG. 14, I-Beam knife 172 is shown as a cantilevered beam knife.
In this implementation, the feature responsible for clamping down
anvil plate 126 is set in front of knife 172, which transects the
tissue. In this way, knife 172 cannot cut tissue without the tissue
already being fastened with staples because the cantilever beam
escapes anvil assembly 122 before knife 172, allowing end effector
jaws 120 and 140 to be opened when knife 172 is in the proximal
position. In this implementation, if tissue is present in the no
tissue zone, the tissue may be stapled but will not be cut.
[0061] FIG. 15 depicts an implementation that utilizes a reversing
knife approach to preventing the transection of unstapled tissue
through the inclusion of a secondary thread on the primary firing
screw. Formed along most of the length of firing screw 500 is a
primary coarse thread 502 that provides enough travel to drive
firing nut 504 from the distal end of end effector 100 to the
proximal end thereof, cutting and firing staples longitudinally
along the end effector. On the proximal end of firing screw 500
secondary thread segment 506 is formed having thread 506, which is
finer that primary thread 502. The pitch and travel of secondary
thread 506 are proportional to primary thread 502. Firing nut 504
rides along primary coarse thread 502 only and limit switch nut 508
rides along secondary fine thread 506 only. When firing screw 500
is turning, firing nut 504 and limit switch nut 508 move in the
same direction but at different linear velocities and therefore
travel different distances. Limit switch nut 508 will travel in
between two limit switches, distal limit switch 510 and proximal
limit switch 512 (see FIG. 15). Before end effector 100 is fired,
firing nut 504 will be at the distal end of the end effector and
limit switch nut 508 will be activating distal limit switch 510.
After end effector 100 has fired, firing nut 504 will be at the
proximal end of the end effector and limit switch nut 508 will be
activating proximal limit switch 512.
[0062] FIG. 16 depicts an implementation that utilizes a reversing
knife approach to preventing the transection of unstapled tissue
through the inclusion of a secondary fine thread on an auxiliary
firing screw. This implementation is similar to what shown in FIG.
15; however, auxiliary firing screw 514 obtains its rotation from
firing screw 502 by way of meshed gears 516 and 518. In either
implementation, primary firing screw 500 or auxiliary firing screw
514 may be any combination of left-handed or right-handed
threads.
[0063] FIG. 17 depicts an implementation of end effector 100,
wherein the jaws of end effector 100 are shown in an open position
and where tissue-blocking elastomeric band 348 has been mounted on
attachment screw 340 on upper jaw 120 and attachment screw 342 on
lower jaw 140. FIG. 18 depicts end effector 100, where the jaws of
end effector 100 are shown in an open position and where
tissue-blocking elastomeric band 348 has been mounted on attachment
screws 340 and 344 on upper jaw 120 and attachment screws 342 and
346 on lower jaw 140 in a crossed configuration. FIG. 19 depicts
end effector 100, wherein the jaws of end effector 100 are shown in
an open position and where tissue-blocking elastomeric band 348 has
been mounted on attachment screw 340 on upper jaw 120 and
attachment screws 342 and 344 on lower jaw 140 in a triangular
configuration. Elastic band 348 may be silicone, urethane, or
similar material, and may be a full loop or an elastic string. In
alternate implementations, the attachments screws are replaced with
rivets, glued posts, welded posts, or stamped or molded features
formed on upper and lower jaws 120 and 140.
[0064] FIG. 20 depicts an implementation of end effector 100, where
the jaws of end effector 100 are shown in an open position and
wherein tissue-blocking rotating post 350 has been positioned
between upper and lower jaws 120 and 140 of end effector 100. In
the implementation shown in FIG. 20, attachment point 342 includes
a torsional spring that biases post 350 in a vertical position.
When jaws 120 and 140 are open, the torsional spring rotates post
350 upward, perpendicular to cartridge frame 144. When jaws 120 and
140 close, a moment is applied to post attachment point 342 by way
of anvil frame 124 on the end of post 350 that counteracts the
force on the torsional spring and rotates post 350 counterclockwise
or clockwise until post 350 is parallel, or nearly parallel, to
cartridge frame 144. FIG. 20 also depicts an alternate
configuration, wherein the end of post 350 opposite attachment
point 342 is constrained by cam profile 352 on anvil frame 124, and
wherein the end of post 350 opposite attachment point 342 acts as
cam follower 354. As jaws 120 and 140 open, cam profile 352 forces
cam follower 354 into a vertical position, perpendicular to
cartridge frame 144. As jaws 120 and 140 close, cam profile 352
forces cam follower 354 into a horizontal position, parallel, or
nearly parallel, to cartridge frame 144. This implementation may
include any combination of a torsional spring, and cam profile and
cam follower.
[0065] FIG. 21 depicts an implementation of end effector 100,
wherein the jaws of end effector 100 are shown in an open position
and wherein tissue-blocking telescoping post 360 has been
positioned between upper and lower jaws 120 and 140 of end effector
100. In the implementation shown in FIG. 21, post 360 does not
rotate but telescopically translates in a vertical manner.
Telescoping post 360 may be biased upward using a compression
spring that is compressed when jaws 120 and 140 close. When jaws
120 and 140 open, the compression spring forces the inner
telescopic members of post 360 upward. A structure such as, for
example, a ball and socket joint, may be included on anvil frame
124 for constraining the lateral movement of telescoping post 360
and providing a surface for compressing post 360. This structure or
feature may be attached to anvil frame 124 using screws, rivets,
glue, welding, or by using features stamped or molded into anvil
frame 124.
[0066] FIG. 22 depicts an implementation of end effector 100, where
the jaws of end effector 100 are shown in an open position and
wherein tissue-blocking curved linkage 362 has been positioned
between upper and lower jaws 120 and 140 of end effector 100. In
the implementation shown in FIG. 22, curved linkage 362 is used to
clamp upper jaw 120 to lower jaw 140. Curved linkage 362 is pinned
in anvil frame 124 wherein it rotates freely. Curved linkage 362
pivots or slides near cartridge 150 as it is pushed or pulled from
inside support tube 190 to open or close jaws 120 and 140. Curved
linkage 362 is present inside the no tissue zone, thereby shielding
tissue from entering it, and is bowed to allow adjacent tissue in
jaws 120 and 140 to be pushed out of the no tissue zone.
[0067] FIG. 23 depicts an implementation of end effector 100, where
the jaws of end effector 100 are shown in an open position and
wherein tissue-blocking passive curved linkage 362 has been
positioned between upper and lower jaws 120 and 140 of end effector
100. In the implementation shown in FIG. 23, curved linkage 364
includes a passive band that cooperates with a separate linkage.
The band is pinned on upper jaw 120 at 340 and pivots in lower jaw
140 at pivot point 342. The passive band does not mechanically
clamp jaws 120 and 140 together but shields the no tissue zone. The
passive band is pulled underneath the separate link when jaws 120
and 140 are closed. When jaws 120 and 140 are opened, the passive
band is bowed and present in the no tissue zone.
[0068] FIG. 24 depicts an implementation of end effector 100, where
the jaws of end effector 100 are shown in an open position and
where a tissue-blocking pivoting double linkage 365 has been
positioned between upper and lower jaws 120 and 140 of end effector
100. Double linkage 365, which has an additional degree of freedom
compared to other disclosed implementations, includes first link
366 connected to second link 370 at pivot point 370. When jaws 120
and 140 are closing, pivot point 370 pushes tissue out of the no
tissue zone, if present, and double linkage 365 then folds into
cartridge frame 144. When jaws 120 and 140 are opening, the double
linkage unfolds and becomes a rigid member that shields the no
tissue zone. Double linkage 365 is connected to anvil frame 124 in
a hinged manner at attachment point 340.
[0069] FIG. 25 depicts an implementation of end effector 100,
wherein the jaws of end effector 100 are shown in an open position
and where a tissue-blocking sacrificial cut band 372 has been
positioned between upper and lower jaws 120 and 140 of end effector
100. In the implementation shown in FIG. 25, sacrificial cut band
372 occupies the entire distance between upper and lower jaws 120
and 140 and the entire width of both cartridge frame 144 and anvil
frame 124. Sacrificial cut band 372 is cut or destroyed when I-Beam
knife 172 fires through the band at the end of the firing stroke of
knife 172. The sacrificial band is typically made from a soft
material, such as silicone, urethane, or any other suitable
material, so that knife 172 can effectively fire through the band.
The band shields tissue from the no tissue zone while also allowing
the jaws of the end effector device to close.
[0070] FIG. 26 depicts an implementation of end effector 100, where
the jaws of end effector 100 are shown in an open position and
wherein a tissue-blocking split band 373 has been positioned
between upper and lower jaws 120 and 140 of end effector 100. In
the implementation shown in FIG. 26, split band 373 includes first
band portion 374 and separate second band portion 376 for allowing
I-Beam knife 172 to pass through the separate band portions when
fired. Split band 373 may be attached to cartridge frame 144 or
cartridge 150 on lower jaw 140 and to anvil frame 124 on upper jaw
120. Split band 373 shields tissue from the no tissue zone while
also allowing the jaws of the end effector device to close.
[0071] FIG. 27 depicts an implementation of end effector 100,
wherein the jaws of end effector 100 are shown in an open position
and where tissue-blocking compliant sacrificial foam block 380 has
been positioned between upper and lower jaws 120 and 140 of end
effector 100. FIG. 28 depicts an implementation of end effector
100, where the jaws of end effector 100 are shown in an open
position and wherein tissue-blocking compliant sacrificial balloon
382 has been positioned between upper and lower jaws 120 and 140 of
end effector 100. Both compliant sacrificial foam block 380 and
compliant sacrificial balloon 382 can permit I-beam knife 172 to
pass through the area of end effector 100 occupied by these
elements or features. Compliant sacrificial foam block 380 may be
attached to anvil frame 124, cartridge frame 144, cartridge 150, or
may be simply constrained by the components surrounding the no
tissue zone. The block is compliant, in an example, and may be
fabricated from an open cell foam or closed cell foam, and allows
upper and lower jaws 120 and 140 to clamp together. The block can
include a specific density that allows I-Beam knife 172 to fire
through it when compressed. The compliant block may be sacrificial
and may be destroyed from the firing sequence of end effector 100.
Compliant sacrificial balloon 382 can be a gas filled compliant
balloon, rather than a block, that allows upper and lower jaws 120
and 140 to clamp together without bursting and may be destroyed
from the firing sequence of end effector 100. The compliant balloon
may be attached to anvil frame 124, cartridge frame 144, cartridge
150, or may be simply constrained by the components surrounding the
no tissue zone.
[0072] FIG. 29 depicts an implementation of end effector 100,
wherein the jaws of end effector 100 are shown in an open position
and wherein tissue-blocking zero clearance block 383 having top
portion 384 and bottom portion 386 has been positioned between
upper and lower jaws 120 and 140 of end effector 100. In the
implementation shown in FIG. 29, zero clearance block 383 is
neither compliant nor sacrificial, but rather is a rigid tapered
block attached to both upper and lower jaws 120 and 140 that pushes
clamped tissue out of the no tissue zone. Both top portion 384 and
bottom portion 386 can include a centrally placed channel or gap
that permits I-beam knife 172 to travel through each portion. Rigid
tapered block 383 may be a structure integrated into anvil frame
124 and cartridge frame 144 (or cartridge 150) or it may be a
separate component fabricated from rigid plastic such as nylon or
from metal such as stainless steel. If the rigid tapered block is a
separate component, it may be attached to upper and lower jaws 120
and 140 by gluing, welding, snap features, or with hardware such as
bolts or screws. The rigid block may produce zero clearance in the
no tissue zone when the jaws of end effector 100 are closed.
[0073] FIGS. 30 and 31 depict alternate devices and methods of
shielding the no tissue zone by using an accordion-like shield that
can "fan out" when the jaws of the end effector are open and "fold
in" when the jaws of the end effector are closed. Example devices
can be attached to upper and lower jaws 120 and 140 to give the
shield two or more anchor points when pulled apart. These
accordion-like devices may be fabricated from a rigid or flexible
metal or plastic or any other suitable material. FIG. 30 depicts an
implementation of end effector 100, where the jaws of end effector
100 are shown in an open position and where accordion shield 388
has been positioned between upper and lower jaws 120 and 140 of end
effector 100. Accordion shield 388 extends along each side of the
no tissue zone and maintains its overall footprint when extended.
In this implementation, I-Beam knife 172 can travel in-between the
two sides of the accordion shield. FIG. 31 depicts an
implementation of end effector 100, where the jaws of end effector
100 are shown in an open position and where fan shield 390 has been
positioned between upper and lower jaws 120 and 140 of end effector
100. In the implementation shown in FIG. 31, fan shield 390 fans
out distally when extended and extends in a semi-circular pattern
from a central axis inside the no tissue zone. Fan shield 390 may
be sacrificial, destroyed by knife 172 during the firing sequence
of end effector 100, or it may be split into two separate fans to
allow knife 172 to pass through the no tissue zone.
[0074] FIG. 32 depicts an implementation that utilizes a
disengaging I-beam knife approach (normal orientation) to prevent
the transection of unstapled tissue and FIG. 33 depicts an
implementation that utilizes a disengaging I-beam knife approach
(disengage orientation) to prevent the transection of unstapled
tissue. In the implementations shown in FIGS. 32 and 33, I-beam top
shelf 174 can be disengaged from anvil plate 126 at proximal tissue
stop 154. In these implementations, knife 172 stops at proximal
tissue stop 154 or in front of the no tissue zone, but I-beam top
shelf 174 may continue on a separate linear travel mechanism until
it clears anvil plate 126 as shown in FIG. 33. Alternately, I-beam
top shelf 174 may become free from I-Beam 170 by means of a
mechanical fuse or the like, thereby allowing upper jaw 120 to open
relative to lower jaw 140. In a similar fashion, I-beam bottom
shelf 176 may be disengaged. I-beam top shelf 174 may be disengaged
from anvil frame 124 and I-beam bottom shelf 176 may become
disengaged from cartridge frame 144 by a trap door or a moving door
mechanism, allowing the end effector jaws to open without being
constrained by the top and/or bottom shelf.
[0075] FIG. 34 depicts an implementation that utilizes an external
device referred to as an introducer sheath to shield the no tissue
zone. In the implementation shown in FIG. 34, introducer sheath 600
is not fixed to end effector 100, but slides longitudinally along
the stapling instrument and may be concentric to the end effector
100. Introducer sheath 600 may cooperate with a trocar, a shielding
sheath, or another device. Shielding sheath 602 may be flexible in
the no tissue zone location, allowing the end effector jaws to
open, close, and fit through a trocar while still shielding the no
tissue zone.
[0076] All literature and similar material cited in this
application, including, but not limited to, patents, patent
applications, articles, books, treatises, and web pages, regardless
of the format of such literature and similar materials, are
expressly incorporated by reference in their entirety. Should one
or more of the incorporated references and similar materials
differs from or contradicts this application, including but not
limited to defined terms, term usage, described techniques, or the
like, this application controls.
[0077] As previously stated and as used herein, the singular forms
"a," "an," and "the" refer to both the singular as well as plural,
unless the context clearly indicates otherwise. The term
"comprising" as used herein is synonymous with "including,"
"containing," or "characterized by," and is inclusive or open-ended
and does not exclude additional, unrecited elements or method
steps. Although many methods and materials similar or equivalent to
those described herein can be used, particular suitable methods and
materials are described herein. Unless context indicates otherwise,
the recitations of numerical ranges by endpoints include all
numbers subsumed within that range. Furthermore, references to "one
implementation" are not intended to be interpreted as excluding the
existence of additional implementations that also incorporate the
recited features. Moreover, unless explicitly stated to the
contrary, implementations "comprising" or "having" an element or a
plurality of elements having a particular property may include
additional elements whether or not they have that property.
[0078] The terms "substantially" and "about" used throughout this
specification are used to describe and account for small
fluctuations, such as due to variations in processing. For example,
these terms can refer to less than or equal to .+-.5%, such as less
than or equal to .+-.2%, such as less than or equal to .+-.1%, such
as less than or equal to .+-.0.5%, such as less than or equal to
.+-.0.2%, such as less than or equal to .+-.0.1%, such as less than
or equal to .+-.0.05%, and/or 0%.
[0079] Underlined and/or italicized headings and subheadings are
used for convenience only, do not limit the disclosed subject
matter, and are not referred to in connection with the
interpretation of the description of the disclosed subject matter.
All structural and functional equivalents to the elements of the
various implementations described throughout this disclosure that
are known or later come to be known to those of ordinary skill in
the art are expressly incorporated herein by reference and intended
to be encompassed by the disclosed subject matter. Moreover,
nothing disclosed herein is intended to be dedicated to the public
regardless of whether such disclosure is explicitly recited in the
above description.
[0080] There may be many alternate ways to implement the disclosed
inventive subject matter. Various functions and elements described
herein may be partitioned differently from those shown without
departing from the scope of the disclosed inventive subject matter.
Generic principles defined herein may be applied to other
implementations. Different numbers of a given module or unit may be
employed, a different type or types of a given module or unit may
be employed, a given module or unit may be added, or a given module
or unit may be omitted.
[0081] It should be appreciated that all combinations of the
foregoing concepts and additional concepts discussed in greater
detail herein (provided such concepts are not mutually
inconsistent) are contemplated as being part of the disclosed
inventive subject matter. In particular, all combinations of
claimed subject matter appearing at the end of this disclosure are
contemplated as being part of the inventive subject matter
disclosed herein. While the disclosed inventive subject matter has
been illustrated by the description of example implementations, and
while the example implementations have been described in certain
detail, there is no intention to restrict or in any way limit the
scope of the appended claims to such detail. Additional advantages
and modifications will readily appear to those skilled in the art.
Therefore, the disclosed inventive subject matter in its broader
aspects is not limited to any of the specific details,
representative devices and methods, and/or illustrative examples
shown and described. Accordingly, departures may be made from such
details without departing from the spirit or scope of the general
inventive concept.
* * * * *