U.S. patent application number 14/126477 was filed with the patent office on 2014-06-26 for linear staple with a multi-functional retaining pin subassembly.
The applicant listed for this patent is ETHICON ENDO-SURGERY, INC.. Invention is credited to Xiangchun Hong, Wei Sun, Shan Wan, Lian Xu.
Application Number | 20140175151 14/126477 |
Document ID | / |
Family ID | 46276050 |
Filed Date | 2014-06-26 |
United States Patent
Application |
20140175151 |
Kind Code |
A1 |
Wan; Shan ; et al. |
June 26, 2014 |
Linear Staple with a Multi-Functional Retaining Pin Subassembly
Abstract
The present invention provides a linear stapler having a
multi-functional retaining pin subassembly. The linear stapler
comprises a handle stem connecting an anvil to a handle, and the
retaining pin subassembly is movably supported on the handle stem
and comprises a connecting cover having a retaining pin extending
from the connecting cover. The present invention also provides a
multi-functional retaining pin subassembly. The retaining pin
subassembly can achieve cartridge alignment and tissue retention
during the firing of the stapler and protect tissue from unintended
damage.
Inventors: |
Wan; Shan; (Mason, OH)
; Hong; Xiangchun; (Shanghai, CN) ; Xu; Lian;
(Shanghai, CN) ; Sun; Wei; (Shanghai, CN) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
ETHICON ENDO-SURGERY, INC. |
Cincinnati |
OH |
US |
|
|
Family ID: |
46276050 |
Appl. No.: |
14/126477 |
Filed: |
June 7, 2012 |
PCT Filed: |
June 7, 2012 |
PCT NO: |
PCT/US2012/041307 |
371 Date: |
March 12, 2014 |
Current U.S.
Class: |
227/176.1 |
Current CPC
Class: |
A61B 2017/07271
20130101; A61B 17/072 20130101; A61B 2017/07278 20130101 |
Class at
Publication: |
227/176.1 |
International
Class: |
A61B 17/072 20060101
A61B017/072 |
Foreign Application Data
Date |
Code |
Application Number |
Jun 21, 2011 |
CN |
201110189676.6 |
Claims
1. A linear stapler (1), comprising: a body (2) for supporting a
cartridge (9) having one or more surgical staples, wherein the body
(2) has a driver (15) for acting on the cartridge (9) to drive the
surgical staples therefrom; the body (2) has a handle stem (20)
supporting an anvil (7) against which tissue can be pressed by the
cartridge (9) for stapling; and a retaining pin subassembly (10)
movably supported on the handle stem (20), wherein the retaining
pin subassembly (10) comprises a connecting cover (12) having a
retaining pin (11) extending therefrom, the connecting cover (12)
being capable of covering an opening of the handle stem (20).
2. The linear stapler (1) according to claim 1, wherein the
retaining pin (11) extends in a direction substantially parallel to
the direction of slide of the connecting cover (12) but is off set
upward therefrom 1 cm to 10 cm.
3. The linear stapler (1) according to claim 1, wherein the
retaining pin (11) extends in a direction aligned with a direction
of slide of the connecting cover (12).
4. The linear stapler (1) according to claim 1, wherein the
connecting cover (12) has a base (19) for the retaining pin
(11).
5. The linear stapler (1) according to claim 1, wherein the
connecting cover (12) has at its proximate end a push lever (13)
extending at an angle from a sliding direction of the connecting
cover (12).
6. The linear stapler (1) according to claim 1, wherein the
connecting cover (12) is made of a metal material.
7. The linear stapler (1) according to claim 1, wherein a plurality
of legs (14) extends downwardly from the connecting cover (12).
8. The linear stapler (1) according to claim 7, wherein the
plurality of legs (14) are provided in pairs and have bumps (18)
facing each other, the connecting cover (12) snap fits on sides of
the handle stem (20) via the bumps (18).
9. The linear stapler (1) according to claim 7 or 8, wherein the
legs (14) are elastic.
10. The linear stapler (1) according to claim 1, wherein the handle
stem (20) includes left and right handle plates.
11. The linear stapler (1) according to claim 1, wherein the
retaining pin subassembly (10) is undetachably connected to the
handle stem (20) via a locking device.
12. A retaining pin subassembly (10) for use in a linear stapler
(1), the linear stapler (1) comprises a handle stem (20) connecting
an anvil (7) to a handle (4), wherein the retaining pin subassembly
(10) is movably supported on the handle stem (20) and comprises a
connecting cover (12) having a retaining pin (11) extending
therefrom, the connecting cover (12) being capable of covering an
opening of the handle stem (20).
Description
FIELD OF THE INVENTION
[0001] The present invention generally relates to a surgical
stapler, and more particularly, to a linear stapler having a
multi-functional retaining pin subassembly.
BACKGROUND OF THE INVENTION
[0002] More and more surgeons tend to use surgical staples, rather
than conventional sutures since the use of surgical staples and
surgical staplers can make many complex procedures much simpler and
thereby reduce operation time. Many types of surgical staplers have
been devised for different procedures, including linear
staplers.
[0003] Over time, linear surgical staplers have evolved with
significant improvements. These instruments generally include a
pair of jaws cooperating with each other and supporting anvil and
staple cartridge, respectively. The instruments also include a
driver within the cartridge casing that pushes all of the staples
out simultaneously against the anvil to form the staples into a
generally B-shape, suturing tissue together. In addition, these
instruments include approximation mechanisms that allow the
cartridge housing and anvil to move relative to each other to
accept tissue therebetween. Finally, the instruments include a
handle and an activating "firing" mechanism. A surgeon moves the
driver forward to form the staples against the anvil by actuating
the firing mechanism with a firing trigger.
[0004] Although such instruments can staple tissue well, there is
still room for improvement. For example, the current linear
staplers often use left and right handle plates in the form of
frame plate to connect the jaws to the handle and a driving
mechanism is received in a space formed by the handle plates. Since
the space formed by the handle plates is open, tissue is prone to
be damaged for being trapped in the space during the insertion and
firing of the instruments. U.S. Pat. No. 4,527,724 discloses a
disposable linear stapler, in which a separate spacer is provided
between the left and right handle plates. The spacer closes the
space to some extent. However, as a large number of components
usually means higher product cost and lower reliability for medical
instruments, that instrument is not preferable.
[0005] For another example, a conventional alignment and retaining
pin takes the form of a slim pin/wire extending from a position
near the proximate end (i.e., the end with the handle) of the
instruments up to its distal end (opposite end to the proximate
end) to facilitate the manipulation by a surgeon. As a result, this
kind of slim pin/wire with a long length inevitably limits the
strength and robustness of the instrument.
[0006] Besides, it is also desirable to enhance the cleanability of
a disposable and reusable linear stapler while maintaining its
performance to make the cleansing work (i.e. assembly, disassembly,
cleaning, sterilization and the like) easier.
[0007] The present invention is directed to improvements in one or
more aspects as set forth above.
SUMMARY OF THE INVENTION
[0008] The present invention provides a linear stapler comprising:
a body for supporting a cartridge having one or more surgical
staples, wherein the body has an driver for acting on the cartridge
to drive the surgical staples therefrom; and wherein the body has a
handle stem supporting an anvil against which tissue can be pressed
by the cartridge for stapling; and a retaining pin subassembly
movably supported on the handle stem, wherein the retaining pin
subassembly comprises a connecting cover having a retaining pin
extending therefrom, the connecting cover being capable of covering
an opening of the handle stem.
[0009] The retaining pin can be used for alignment. In one
embodiment, the retaining pin extends in a direction substantially
parallel to the direction of slide of the connecting cover but is
off set upward therefrom 1 cm to 10 cm. In another embodiment, the
retaining pin extending in a direction aligned with the direction
of slide of the connecting cover in the linear stapler.
[0010] In one embodiment, the handle stem can be a handle
plate.
[0011] According to one embodiment, the connecting cover includes a
base for the retaining pin.
[0012] According to one embodiment, the connecting cover is
provided at its proximate end a push lever extending at an angle
from the sliding direction of the connecting cover (for example,
the angle can be an upwardly angle), and the push lever can be
manipulated manually.
[0013] According to one embodiment, the connecting cover is made of
a metal material.
[0014] According to one embodiment, a plurality of legs (e.g.,
arranged as pairs of legs) extends downwardly from the connecting
cover. Furthermore, the plurality of legs have bumps extending
inwardly (e.g., such as when the legs have inward facing surfaces
facing across the width of the connecting cover "inner surfaces"
and the bumps are on the legs' inner surfaces) facing each other,
the connecting cover snap fits on sides of the handle plate via the
bumps.
[0015] According to one embodiment, the legs are elastic.
[0016] According to one embodiment, the handle stem includes left
and right handle plates.
[0017] According to one embodiment, the retaining pin subassembly
is undetachably connected to the handle stem via a locking
device.
[0018] The present invention also provides a multi-functional
retaining pin subassembly for use in a linear stapler, the linear
stapler comprises a handle stem connecting an anvil to a handle,
and wherein the retaining pin subassembly is movably supported on
the handle stem and comprises a connecting cover having a retaining
pin extending therefrom, the connecting cover being capable of
covering an opening of the handle stem.
[0019] The retaining pin subassembly according to the present
invention may serve multiple functions. For example, it can be an
alignment and retaining pin to enhance the disposable or reusable
cartridge alignment to ensure proper staple firing. And the
retaining pin can also serve its retaining function to retain
tissue between the anvil and cartridge during the staple firing.
Also, the connecting cover may act as a top cover to reduce the
openness of the instrument and avoid the possible tissue damage
during the insertion and firing of the instrument. Meanwhile, as a
structural part, the connecting cover in its shape and material
(e.g., plate shape and made of steel) advantageously improves the
strength and robustness of the retaining pin subassembly.
Preferably, the small bumps on the connecting cover interacting
with the retaining pin guide can provide tactile feedback to
surgeons that the retaining pin is in the right position.
[0020] Compared with the prior art, the present invention reduces
the number of components, improves the reliability of the
instrument, and makes it easy to clean and sterilize without
compromising its performance by forming a retaining pin subassembly
with a connecting cover and a retaining pin.
BRIEF DESCRIPTION OF THE DRAWINGS
[0021] Other features and advantages of the present invention will
become apparent from the following detailed description when viewed
in conjunction with the accompanying drawings, which set forth
certain exemplary but non-limiting embodiments of the
invention.
[0022] FIG. 1 is a perspective view of a linear stapler in prior
art;
[0023] FIG. 2 is a partially-cut-out view of some components of the
linear stapler shown in FIG. 1;
[0024] FIG. 3 is a schematic diagram of a linear stapler with a
retaining pin subassembly in accordance with one exemplary
embodiment of the present invention;
[0025] FIG. 4 is a perspective view of the retaining pin
subassembly shown in FIG. 3;
[0026] FIGS. 5-9 illustrate a locking device according to different
embodiments of the present invention, respectively.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0027] In the following, certain exemplary embodiments will be
described in detail with reference to the accompanying drawings, in
which like numeral signs are used for like components.
[0028] Referring to drawings, FIG. 1 illustrates an exemplary
linear stapler 1 in prior art schematically showing the basic
construct thereof. The linear stapler 1 includes a body 2 for
supporting a cartridge 9 with one or more surgical stapler. The
body 2 also has a driver 15 acting upon the cartridge 9 to expel
the surgical stapler therefrom. Specifically, as shown, the body 2
includes a handle 4 and a trigger 3 pivotally connected with the
handle 4 at a proximate end. A fixed jaw 6 supporting an anvil 7
and a movable jaw 8 including a cartridge 9 are provided at a
distal end of the linear stapler 1. The cartridge 9 is removably
inserted in the linear stapler so that it can be removed after
use.
[0029] A cartridge/driver assembly, i.e. the movable jaw 8,
comprises the cartridge 9, a staple driver 15, a casing 16, a
driver rod 17 and the like. The cartridge 9 can constitute an
integral, one piece member (typically made with molded plastic,
although other material can be used) and can be reused by reloading
staples. The linear stapler can be reused by removing a spent empty
cartridge and loading with a new cartridge with staples. "Plastic
member" used herein refers to a member formed of a plastic material
of adequate strength, suitable for use in a surgical environment,
and capable of sterilization by one or more known accepted methods.
The cartridge 9 contains a plurality of staple-containing slots 34
for rows of staples. A driver 15 is disposed in the casing 16 and
behind the cartridge 9, for expelling all the staples
simultaneously out of the staple-containing slots 34. For example,
the driver 15 can be a mechanical member having a plurality of tips
24 aligned with the surgical staples contained in the
staple-containing slots 34 for pushing the staples. It can also be
a balloon hydraulically or pneumatically actuated. The driver rod
17 may be a metal member having elongate shank with one distal end
contained in the casing 16 and interacting with the driver 15 and
one proximate end engaged with the trigger 3. The trigger 3
interacts with the driver rod 17 to push it and thus the driver 15
distally to fire staples when the trigger 3 is pulled towards the
handle 4.
[0030] The anvil 7 has a staple-shaping surface for forming the
staples into a generally B-shape in order to achieve tissue
engagement. Once tissue to be stapled is positioned between the
anvil 7 and cartridge 9, the trigger 3 may be actuated by a surgeon
to fire staples towards the staple-forming surface of the anvil 7
to form the staples, thereby stapling the tissue.
[0031] In addition, the body 2 further includes a handle stem 20
supporting the anvil 7. The fixed jaw 6 is connected to the handle
4 via the handle stem 20 having handle plates 2 each in the form of
a frame plate. The handle stem 20 can include left and right handle
plates, for example. They typically are made of metal and
constitute the "main frame" of the linear stapler. Said driver rod
17 is located between the left and right handle plates and capable
of moving distally under the actuation of the trigger 3 as
mentioned above.
[0032] The linear stapler 1 further comprises a multi-functional
retaining pin subassembly 10 supported on the handle stem 20.
[0033] As shown in FIG. 3, the exemplary retaining pin subassembly
10 includes a retaining pin 11 with a connecting cover 12 extending
therefrom. The connecting cover 12 may be a cover plate extending
distally from a position near the proximate end of the linear
stapler 1 and slidably covering on an opening above the left and
right handle plates. The opening provides accessibility, for
example, for placement and removal of parts that serve actuating
functions, such that the linear stapler can be disassembled for
cleaning. The width of the connecting cover 12 is sized to enable
it to cross and almost across the left and right handle plates 2.
During the insertion and firing of linear stapler 1, the connecting
cover 12 closes the opening which would otherwise be expose to
tissue as in the prior art instruments and therefore have a risk of
tissue damage by trapping tissue therein. A base 19 for the
retaining pin 11 is located on the distal end of the connecting
cover 12. The retaining pin 11 extends distally from the base 19.
As shown in FIG. 2, the cartridge 9 and the casing 16 each have a
channeling hole 27, 43 through which the retaining pin 11 can
extend. The distal end of the retaining pin 11 may be contained in
the casing 16 and extend to anvil 7 by passing through the
channeling holes 27, 43 on the casing 16 and cartridge 9.
Correspondingly, a hole 71 can be formed on the anvil 7 for
receiving the forwardmost end of the retaining pin 11, as shown in
FIG. 1.
[0034] The connecting cover 12 extends at an angle (e.g., about
perpendicularly upwardly from the surface of the connecting cover
12) with its tail 13 at a proximate end to form an upstanding
pushing lever 13 that a surgeon can manipulate manually. A force
can be applied to the pushing lever 13 to move the connecting cover
12 and thereby the retaining pin 11 distally, until the retaining
pin 11 reaches the anvil 7. The retaining pin 11 and connecting
cover 12 are both reusable. They can be manufactured separately and
assembled together. Alternatively, the retaining pin subassembly 10
can be formed integrally, such as by molding. The connecting cover
12 may be made of medical plastic and metal with suitable
strength.
[0035] Preferably, two pairs of legs 14 extend downwardly from the
bottom surface of the connecting cover 12 along its length and the
retaining pin subassembly 10 is slidably supported on the handle
stem 20 via these legs 14. In particular, two small bumps 18 may be
formed on the surfaces of each pair of the legs 14 to face each
other in the pair. For example, when the opposing inner surfaces of
the legs 14 have a distance across the wide of the connecting cover
12 therebetween, bumps extending inwardly may be disposed in pairs
on the inner surface of the legs 14. Preferably, the legs 14 may be
elastic such that the connecting cover 12 can snap on the sides of
the handle stem 20. Although a connecting cover 12 with two pairs
of legs 14 and four bumps 18 is shown in the drawings, the number
of legs and bumps may be varied. It can be understood that instead
of the plurality of legs, a single continuing wall may be formed on
each sides of the connecting cover 12 and each wall can be
considered as a leg. Furthermore, the connecting cover 12 may be
supported on the handle stem 20 in various ways, as long as it is
slidable with respect to the handle stem 20.
[0036] The retaining pin subassembly 10 is movable between a
retracted position and an extended position. In the retracted
position, the forwardmost end of the retaining pin 11 passes
through the channeling hole 43 on the casing 16 and the retaining
pin 11 is located in the casing 16. Once the tissue to be sutured
is positioned between the anvil 7 and the movable jaw 8, the
pushing lever 13 is manipulated to move the retaining pin 11
distally. This causes the forwardmost end of the retaining pin 11
to pass through the channeling hole 27 in cartridge 9 and into the
hole 71 on anvil 7, i.e., reach the extended position. In this
extended position, the retaining pin 11 assures proper alignment of
anvil 7 and cartridge 9 so that the staples will be properly
aligned with the anvil pockets on the staple-forming surface of
anvil 7 when the linear staple is fired. Furthermore, in this
extended position, the retaining pin 11 spans the distance between
the anvil 7 and cartridge 9, assuring that tissue located
therebetween will remain therebetween during operation of the
linear stapler 1.
[0037] Therefore, the retaining pin subassembly 10 achieves the
cartridge alignment and tissue retention effectively. Besides, by
employing the novel connecting cover 12 having the retaining pin 11
at its distal end, the retaining pin 11 does not have to extend
from the proximate end up to the distal end of the linear stapler 1
as the conventional design does. Therefore, the retaining pin
subassembly 10 will have higher strength and robustness compared to
the prior art since the length of the slim pin/wire is
significantly reduced and the pin 11 is supported by the connecting
cover 12. Also, with the connecting cover 12 covering the opening
between the handle stem 20, tissue damage for being trapped in the
opening can be avoided without increasing the number of
components.
[0038] As such, the retaining pin subassembly 10 is substantially
improved in both structure and operability, which is of great
importance to tissue stapling. However, a surgeon might sometimes
forget to assemble the retaining pin subassembly, which will result
in risks in performance of the device. Therefore, it is of great
medical value to have a mechanism which can ensure a user such as a
surgeon will not forget to assemble the retaining pin subassembly.
Accordingly, the present invention preferably provides a locking
device which ensures the retaining pin subassembly to be retained
together with the handle stem so that the user will not miss the
retaining pin subassembly during the reusable apparatus assembly
process.
[0039] Specifically, as shown in FIG. 5, the connecting cover 12
can be pulled back to an end portion of the handle stem 20, and the
connecting cover 12 cannot be disengaged from the handle stem 20.
This can be achieved in various manners. For example, a recess 22
(only one recess is shown in the figure) is formed on the left and
right handle plates, the connecting cover 12 is provided with a
boss (not shown) which is slideable in the recess 22 and retains
the connecting cover 22 and prevents it from disengaging from the
handle stem 20.
[0040] According to another embodiment, as shown in FIG. 6, a
closed ring 23 is disposed on the handle stem 20 and sized so that
the base 19 of the retaining pin subassembly 10 and the tail 13
cannot pass therethrough such that the retaining pin subassembly 10
cannot be disengaged from the handle stem 20. As shown in the
figure, the retaining pin subassembly 10 can be turned 90 degrees
and received in the opening of the handle stem 20, thereby forming
a space for assembling other components such as a closure
member.
[0041] According to a further embodiment as shown in FIG. 7, a
sidewall 21 is formed on both sides downwardly along a length of
the connecting cover 12, a pair of grooves 25 are respectively
formed on the sidewall 21 along the length, a through hole 26 is
formed at the proximal end of the handle stem, a pin (not shown)
passes through the through hole 26 in the handle stem and grooves
25 in the sidewall 21 to engage the handle stem 20 together with
the retaining pin subassembly 10. It can be seen that through
engagement of the pin and the grooves 25, the retaining pin
assembly 10 is slideable on the handle stem 20 and rotatable about
the pin. In this way, the retaining pin subassembly 10 and the
handle stem 20 are locked together.
[0042] According to another embodiment as shown in FIG. 8, a bore
allowing the pin to pass is formed on the proximal end of the
sidewall 21 and the proximal end of the handle stem 20. The
retaining pin subassembly 10 and handle stem 20 are connected
together via the pin at the proximal ends. Furthermore, the
retaining pin subassembly is wholly pivotal about the pin at said
end, away from the handle stem 20 to open the opening of the handle
stem 20 to expose the members received therein. At this time, the
retaining pin 11 is set to be longitudinally moveable relative to
the base 19. For example, the retaining pin 11 is connected to the
base 19 through threaded engagement so that it can be screwed
distally or proximally relative to the base 19.
[0043] According to a further embodiment as shown in FIG. 9,
instead of the grooves which are formed on the sidewall and are
through the sidewall, non-through slots 28 may be formed on the two
sidewalls along the length of the sidewall 21. A pair of through
holes 29 is formed on for example proximal end of the handle stem,
and two short pins (not shown) respectively retain the retaining
pin subassembly 10 and the handle stem 20 together on both sides.
In this way, the retaining pin subassembly 10 can be engaged in the
slot 28 through the pin and slideable relative to the handle stem
20, and is rotatable about the pin as the rotation center relative
to the handle stem 20.
[0044] Other variations, modifications and substitutions of the
locking device will be apparent to those skilled in the art in view
of the teachings herein.
[0045] The instruments disclosed herein can be designed to be
disposed of after a single use, or they can be designed to be used
multiple times. In either case, however, the instrument can be
reconditioned for reuse after at least one use. Reconditioning can
include any combination of the steps of disassembly of the
instrument, followed by cleaning or replacement of particular
pieces, and subsequent reassembly. In particular, the instrument
can be disassembled, and any number of the particular pieces or
parts of the instrument can be selectively replaced or removed in
any combination. Upon cleaning and/or replacement of particular
parts, the instrument can be reassembled for subsequent use either
at a reconditioning facility, or by a surgical team immediately
prior to a surgical procedure. Those skilled in the art will
appreciate that reconditioning of an instrument can utilize a
variety of techniques for disassembly, cleaning and/or replacement,
and reassembly. Use of such techniques, and the resulting
reconditioned instrument, are all within the scope of the present
application. Furthermore, structures and methods of making such
structures for cartridges, anvil, jaws, handle, actuating firing
mechanism are within the knowledge of those skilled in the art.
[0046] Preferably, the invention described herein will be processed
before surgery. Any suitable sterilization process can be used.
First, a new or used instrument is obtained and if necessary
cleaned. The instrument can then be sterilized. In one
sterilization technique, as an example, the instrument is placed in
a closed and sealed container, such as a plastic or TYVEK bag. The
container and instrument are then placed in a field of radiation
that can penetrate the container, such as gamma radiation, x-rays,
or high-energy electrons. The radiation kills bacteria on the
instrument and in the container. The sterilized instrument can then
be stored in the sterile container. The sealed container keeps the
instrument sterile until it is opened in the medical facility.
[0047] While this invention has been described as having exemplary
designs, the present invention may be further modified within the
principles and scope of the disclosure. This application is
therefore intended to cover any variations, uses, or adaptations of
the invention using its general principles. Further, this
application is intended to cover such departures from the present
disclosure within the known or customary practice in the art.
* * * * *