U.S. patent number 3,844,289 [Application Number 05/350,956] was granted by the patent office on 1974-10-29 for hemostat and attachment for suturing organic tubular structures.
This patent grant is currently assigned to United States Surgical Corporation. Invention is credited to Douglas G. Noiles.
United States Patent |
3,844,289 |
Noiles |
October 29, 1974 |
HEMOSTAT AND ATTACHMENT FOR SUTURING ORGANIC TUBULAR STRUCTURES
Abstract
A hemostat provided with a disposable staple-carrying cartridge
movably attached thereto. The jaws of the hemostat are parted,
through an opening at the forward end of the cartridge, and, for
example, a bleeding organic tubular structure is positioned between
the hemostat jaws. The jaws of the hemostat are closed, clamping
the "bleeder" therebetween, and then the opening at the forward end
of the cartridge is closed. The cartridge is subsequently moved so
that the closed forward end of the cartridge is displaced away from
a position surrounding the hemostat jaws and into a position
surrounding the bleeder. The cartridge is activated by the surgeon,
and a U-shaped staple is urged forward, made to surround the
bleeder and then seals the same. After the seal, the hemostat is
removed. Means are provided for preventing misfiring of the
cartridge when a staple is in an improper position, or when the
cartridge is exhausted of its supply of staples.
Inventors: |
Noiles; Douglas G. (New Canaan,
CT) |
Assignee: |
United States Surgical
Corporation (Baltimore, MD)
|
Family
ID: |
23378938 |
Appl.
No.: |
05/350,956 |
Filed: |
April 13, 1973 |
Current U.S.
Class: |
606/143;
29/243.56 |
Current CPC
Class: |
A61B
17/128 (20130101); Y10T 29/53783 (20150115) |
Current International
Class: |
A61B
17/12 (20060101); A61B 17/128 (20060101); A61b
017/10 (); B23p 011/00 () |
Field of
Search: |
;128/334R,326
;29/243.56,243.57 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Jones, Jr.; James L.
Attorney, Agent or Firm: Fleit, Gipple & Jacobson
Claims
What is claimed is:
1. The method for ligating tubular structures and tissue masses
with surgical staples while the structures to be ligated are
clamped between the clamping jaws of a hemostat, and wherein a
staple-carrying cartridge is moveably mounted on one of two
pivotally connected arms of the hemostat, wherein the cartridge has
a closeable opening adapted to surround the clamping jaws of the
hemostat at the end adjacent said clamping jaws, the closeable
opening allowing for the free passage of the second of the hemostat
arms when the closeable opening is open, the method comprising the
steps of: clamping a structure to be ligated between the clamping
jaws of the hemostat so as to temporarily close the structure;
closing the closeable opening in the cartridge so that the
closeable opening completely encircles the clamping jaws of the
hemostat; moving the closeable opening along the jaws of the
hemostat, past the respective ends thereof, and about the
temporarily closed structure; and ejecting a surgical staple from
the cartridge and clinching the same about the structure clamped
between the jaws of the hemostat so as to permanently close the
structure with a surgical staple.
2. The method recited in claim 1, wherein the cartridge is
pivotally moved with respect to the hemostat.
3. The method recited in claim 1, wherein the cartridge is linearly
moved with respect to the hemostat so that the longitudinal axis of
the cartridge remains parallel to the longitudinal axis of the
hemostat arms.
4. The method recited in claim 1, and further comprising the steps
of: blocking the ejection and clinching of the surgical staple if
the staple is out of position in the cartridge or if the cartridge
is devoid of staples.
5. The method recited in claim 4, wherein said blocking means
comprises a spring member biased toward the plane of the ejecting
and clinching means and adapted to be biased out of said plane by a
surgical staple.
Description
BACKGROUND OF THE INVENTION
In the course of surgical operations, blood vessels are often
severed, and hence it becomes necessary to seal the open ends
thereof to prevent the patient from losing an excessive amount of
blood. It is the general practice to use conventional hemostats to
seal the open blood vessels until the surgeon can manually ligate,
or "tie off" the vessels with suturing material. Recently, in an
attempt to facilitate the ligation procedure, devices have been
developed to mechanically ligate the bleeders and hence to
facilitate the operative procedure. Examples of such mechanical
devices can be found in U.S. Pat. No. 3,576,288, and copending U.S.
Pat. Application Ser. No. 869,242, both being assigned to the
present assignee.
In each of the two above-noted patent documents, there is disclosed
a mechanical stapling apparatus associated with a hemostat. The
vessel to be ligated is gripped by the jaws of the hemostat, the
stapling apparatus is actuated, and a surgical staple is clinched
about the vessel to seal the same. While these mechanical devices
have contributed some measure in solving the problems associated
with the conventional manual ligation of bleeders, all the existing
problems have not been eliminated.
A significant drawback of known mechanical ligation apparatus
relates to the effectiveness of the staple formation. In the known
devices, there exists the threat that the staple will pierce the
vessel and/or the surrounding tissue and result in the incomplete
sealing thereof. A further drawback relates to the complexity of
such known devices. Manufacturing tolerances are very strict, and
hence it becomes rather difficult to ensure the proper functioning
of the assembled device. And also related to the close tolerances,
the known devices tend to be quite susceptible to shock. As an
additional drawback, the known ligation devices are somewhat
difficult to manipulate and operate. Moreover, an important
drawback of the prior art instruments is the lack of total control
over the vessel to be ligated. And still a further disadvantage of
those devices known to the prior art is that the surgeon is able to
activate the stapling assembly even if a staple is out of alignment
or if the stapling assembly is void of staples.
It is toward the elimination of the above drawbacks and
disadvantages associated with the known hemostat ligation
instruments that the present invention is directed.
SUMMARY OF THE INVENTION
The present invention relates to a hemostat and an associated
apparatus for clamping an organic tubular structure and ligating
same with a surgical stapler in an efficient and effective manner.
The inventive apparatus comprises the combination of a specially
designed hemostat nd a disposable staple-carrying cartridge movably
mounted thereon. The hemostat and cartridge associate in such a
manner that when the cartridge is in its retracted position, the
hemostat may be freely operated to clamp a "bleeder" between the
jaws thereof. Then, once the structure to be ligated is properly
positioned in the jaws of the hemostat, the cartridge is moved past
the nose of the hemostat and around the "bleeder." Once in its
stapling position, the cartridge is actuated, a U-shaped staple is
urged toward the "bleeder," and by means of an anvil assembly, the
staple is safely and positively clinched about the "bleeder." The
cartridge is then retracted, and the hemostat is removed.
The cartridge associates with the hemostat so that the hemostat
jaws are free to operate, notwithstanding the presence of the
cartridge. And the cartridge jaws are adapted to close before
associating with the "bleeder," thereby ensuring complete
encirclement of the "bleeder" when the cartridge is in its stapling
position. At the same time the mechanics of the stapling operation
effectively prevents the occurrence of damage to the structure
being ligated.
As should be evident, it is important that the surgeon be made
aware of a jammed staple or an empty cartridge before a ligation is
attempted. Otherwise, serious damage might result to the structure
intended to be ligated. According to one further aspect of the
present invention, means are provided in the cartridge to prevent
the completion of a stapling operation in the event that the
cartridge is empty. Hence, the surgeon is made aware of the need to
replace the cartridge before any damage is done to the patient.
Accordingly, it is an object of the present invention to provide a
combination of elements for effectively clamping and ligating an
organic tubular structure with surgical staples.
It is a more specific object of the present invention to provide a
combination of elements for clamping and ligating an organic
tubular structure in such a manner that sealing of the structure is
ensured.
It is yet a further specific object of the present invention to
provide a combination of elements for clamping and ligating an
organic tubular structure in a manner which avoids damage to such
structure.
Another object of the invention is to provide a combination of
elements for clamping and ligating an organic tubular structure in
a manner which ensures complete control over the structure to be
ligated.
Still a further specific object of the present invention is to
provide a combination of elements for clamping and ligating an
organic tubular structure, including means for preventing damage to
the structure in the event that a staple is misaligned or jammed,
or in the event that the cartridge is empty.
Still another object of the present invention is to provide a
sterile disposable pre-packaged staple-carrying cartridge which is
adapted to be movably mounted on the hemostat, the combination
adapted to clamp and ligate an organic tubular structure.
Another specific object of the present invention is to provide the
combination of a hemostat and a staple-carrying cartridge for
clamping and ligating an organic tubular structure ensuring free
operation of the hemostat when the cartridge is in its stored
position and positive encirclement of the structure to be ligated
when the cartridge is in its stapling position.
These and other objects of the present invention as well as many of
the attendant advantages thereof, will become more readily apparent
when reference is made to the following description taken in
conjunction with the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a plan view of a hemostat equipped with a disposable
staple-carrying cartridge designed in accordance with the teachings
of the present invention;
FIG. 2 is a view of the hemostat-cartridge combination taken along
line 2--2 of FIG. 1;
FIG. 3 is a view similar to FIG. 2 illustrating one stage in the
operation of the inventive hemostat-cartridge combination;
FIG. 4 is a view similar to FIG. 3 illustrating a later stage in
the operation of the inventive hemostat-cartridge combination;
FIG. 5 is a view similar to FIG. 4 but showing the inventive
hemostat-cartridge combination in still a later stage of its
operation;
FIG. 6 is a front view of the inventive hemostat-cartridge
combination;
FIG. 7 illustrates the placement of a staple about a "bleeder;"
FIG. 8 is a view illustrating a hemostat-cartridge combination
designed in accordance with a second embodiment of the present
invention;
FIG. 9 is a view similar to FIG. 8, but showing the
hemostat-cartridge combination in a later stage of its
operation;
FIG. 10 is a cross-section of the inventive cartridge taken along
line 10--10 of FIG. 8; and
FIG. 11 is an enlarged cross-section of the failsafe structure in
the inventive cartridge.
DETAILED DESCRIPTION OF THE DRAWINGS
With reference first to FIGS. 1 through 6, the structure of the
first embodiment of the inventive hemostat-cartridge combination
will be described. The inventive combination is shown generally at
10 and comprises, basically, a hemostat 12 and an attached
disposable staple-carrying cartridge assembly 14. The hemostat 12
comprises a pair of handle portions 16 and 18 integral,
respectively, with jaws 20 and 22. A pivot pin 24 maintains the
hemostat elements as a unit, and a conventional multi-position lock
26 on the handle portions 16 and 18 allows the hemostat to be
clamped in any desired position.
The cartridge assembly 14 is of two-piece design. The first is a
mounting element 28 which is removably fastened on the hemostat 12.
The second is a staple-carrying cartridge 30 slidably mounted on
element 28. Four pins 32 are fixed with respect to the cartridge 30
and are adapted to associate with slots 34 in the mounting elements
28 to guide the cartridge 30 during its movement relative to the
mounting element 28 and the hemostat 12. It should be noted that
the slots 34 substantially parallel the gripping jaws 20 and 22 of
the hemostat 12.
With particular reference now to FIGS. 1, 2 and 6, the association
between the mounting element 28 and the hemostat 12 will be
described. The rear portion of the mounting element 28 takes the
form of an elongated extension 36 terminating in a pair of clips 38
adapted to grip the handle 16 of the hemostat 12. A leaf spring 40
is positioned between the inner surface of extension 36 and the
elongated handle portion 16 of the hemostat 12. The side of the
mounting element 28 opposite the extension 36 is represented by the
numeral 42 which, as best seen in FIGS. 1 and 6, is bent at 44 so
as to contact the jaw 20 of hemostat 12. In this manner, the
integral handle portion 16 and jaw portion 20 of the hemostat 12 is
held between the leaf spring 40 and the surface 44 of the mounting
element 28.
The extension 36 of mounting element 28 is supported by an
intermediate section 46 which, as can best be seen in FIGS. 1 and
2, is cut back at 48. In this manner, the nose portion 22 of the
hemostat 12 is free to open and close without interference from the
mounting element. Forward of the intermediate region 46, and
defining the respective slots 34, is an upper guide plate 50. A
parallel guide plate 52 extends from the mounting element side 42
and serves to define thelower slot 34. The manner in which the
plates 50 and 52 guide the cartridge 30 can be seen in FIG. 6.
With reference now to FIGS. 10 and 11, the specific configuration
of the cartridge 30 will be described. In this connection,
attention is directed to U.S. Pat. Application Ser. No. 64,749 and
U.S. Pat. No. 3,665,924, each assigned to the present assignee. In
each of these documents, there is described a method and an
apparatus for performing a double ligation of tubular structures in
an extremely safe and efficient manner. Generally speaking, this is
accomplished by the C-shape formation of staples about the tubular
structure to be ligated. The cartridge forming a part of the
present invention is similar in many respects to the cartridge
disclosed in the prior art patent documents.
The inventive cartridge 30 generally comprises a main body 54,
preferably of plastic, a three-piece rail assembly 56, the forward
nose of which defines an anvil 58, and a staple pusher and ejector
60. The cartridge 30 is further provided with a first leaf spring
assembly 62 fixedly attached to the plastic main body 54, and a
second leaf spring assembly 64 fixedly attached to the rail
assembly 56. A number of surgical staples 66 are housed in the
cartridge 30 and are adapted to travel, initially, in a feed track
68, and then in an ejection track 70. And as is the case with the
cartridge disclosed in U.S. Pat. No. 3,665,924, the staples are
indexed and moved from the feed track 68 to the ejection track 70
for each cycle of operation and by means of the cooperating leaf
spring assemblies 62 and 64.
As best seen in FIGS. 1 and 3, the inventive cartridge 30 is fit
with a closure sleeve 72 integral with the rear portion of the rail
assembly 56. A lock 73 is defined in the forward portion of the
closure sleeve 72. The cartridge 30 is also provided with a plunger
76 which associates with the rear portion of the pusher 60. As will
be more fully explained below, the closure sleeve 72 and the
plunger 76 control, respectively, the rail assembly 56 and the
pusher 60, and hence control the operation of the cartridge 30.
With specific reference now to FIGS. 1 through 5 and 11, the
operation of the inventive hemostat-cartridge combination will be
described. With the closure sleeve 72 in its forwardmost position
(FIG. 1), the rail assembly 56 is spaced from the main body 54 and
hence defines a gap 78 in the forward end of the cartridge
elements. With the cartridge in this position, the hemostat 12 is
opened, with the upper jaw 22 passing through the cartridge gap 78
and into the position illustrated in phantom in FIG. 1. Then, the
"bleeder" 80 is located and is clamped between the jaws of the
hemostat as illustrated in FIG. 2.
Once the "bleeder" is properly secured between the jaws of the
hemostat 12, the surgeon pulls back on trigger 74, in the direction
of arrow 81 (FIG. 2), so that the rail assembly 56 moves toward the
main body 54 of the cartridge 30. The surgeon continues this
movement until the gap 78 is completely closed (FIG. 3), and the
lock 73 engages the body 54 of the cartridge 30.
With the jaws of the cartridge 30 locked in the closed position,
the surgeon slides the cartridge along the slot 34 and in the
direction of arrows 84, into the position illustrated in FIG. 4. As
should be evident, and because the cartridge jaws are closed when
the cartridge is moved about the "bleeder" 80, there is always
complete control over the position of the "bleeder" relative to the
jaws of the cartridge. Hence, the "bleeder" will always be
completely closed by the action of the surgical staple.
The next step in the operation occurs when the surgeon applies a
force to the plunger 76, in the direction of arrow 86. In this
manner, the pusher 60 moves toward the front of the cartridge 30
and slides the forwardmost staple 66 along the ejection track 70
and the rail assembly 56 ultimately forming the staple 66 around
the "bleeder" 80 and against the anvil 58. At this stage, the
combination takes the form illustrated in FIG. 5. The staple, as is
more fully described in U.S. Pat. No. 3,683,927, takes a C-shape
and hence ensures complete sealing of the "bleeder" 80 while
minimizing the risk of injury thereto. A stapled "bleeder" is
illustrated in FIG. 7.
After the stapling operation is completed, the surgeon retracts the
plunger 76, unlocks and advances the closure sleeve 72, and then
opens the hemostat jaws 20 and 22 thereby releasing the fully
stapled and sealed "bleeder" 80. The cartridge 30 is indexed, as is
fully described in U.S. Pat. No. 3,665,924, when the rail assembly
56 is moved away from the main body 54. This movement causes the
forwardmost staple in the feedtrack 68 to move into the ejection
track 70 in readiness for the next stapling operation, while each
remaining staple in the feed track advances to the next forward
position.
With reference now to FIGS. 8 and 9, a second and simplified
embodiment of the inventive hemostat-cartridge assembly will be
described. In this embodiment, the hemostat 12' is equipped with a
mounting element 28' identical in most respects to that illustrated
in FIGS. 1 through 6. A cartridge 30' also similar in most respects
to the cartridge 30 illustrated in FIGS. 1 through 6, is positioned
on the mounting element 28'. In this embodiment, the mounting
element 28' is equipped with a tab 88 which, by means of pin 90,
pivotally secures the cartridge 30' to the hemostat 12'. It should
be noted that the jaws 92 of the hemostat 12' are shaped so that
the cartridge 30' may pivot from the position illustrated in FIG. 8
to the position illustrated in FIG. 9 without interference from the
jaws.
The inventive hemostat-cartridge combination illustrated in FIGS. 8
and 9 operates similar to the combination illustrated in FIGS. 1
through 6. With a gap defined between the main body 54 and the rail
assembly 56, the hemostat jaws 92 are opened. The "bleeder" is then
positioned between the jaws, and the jaws are closed. Next, the
trigger 74 is retracted, and the gap closed and locked in position.
Then, the cartridge 30' is pivoted, in the direction of arrow 94,
so as to take the position illustrated in FIG. 9. At this point,
the plunger 76 is advanced and the pusher 60 ejects and forms the
forwardmost staple 66 about the 37 bleeder" 80.
Upon completion of the stapling operation, the plunger is
retracted, the lock on the closure sleeve 72 is released, and the
sleeve 72 is advanced. Then, with the rail assembly 56 again spaced
from the body 54 of the cartridge 30', the hemostat jaws are opened
and the stapled "bleeder" is released.
As with the embodiment of the invention illustrated in FIGS. 1
through 6, and in view of the fact that the cartridge is positioned
about the "bleeder" with the cartridge jaws closed, the embodiment
of the invention illustrated in FIGS. 8 and 9 ensures full control
over the "bleeder" in all stages of the positioning and stapling
operations. And because of the cartridge design and stapling
method, the embodiment of the invention illustrated in FIGS. 8 and
9 also ensures that the "bleeder" is effectively stapled without
the fear of damage thereto.
As noted previously, a drawback of the prior art hemostat staplers
is that a full stapling operation may be carried out by the surgeon
even though a staple is misaligned in the cartridge or the
cartridge is void of staples. The inventive cartridge, as will be
more fully explained below, is provided with a fail-safe feature to
block the full operation of the cartridge unless a properly aligned
staple is present in the ejection track 70. This feature of the
inventive cartridge will become clear when reference is made to
FIGS. 10 and 11.
The fail-safe feature of the inventive cartridge depends upon the
interaction of a spring stop 96, the pusher 60 and a staple 66. The
spring stop 96 takes the form of an elongated leaf spring adapted
to fit, at its rear region, about a projection 98 in the cartridge
body 54. Preferably, the projection 98 is integral with and molded
simultaneously with the main body 54. At the forward end of the
spring stop 96 is a cup-shaped extension 100 having a shape
substantially conforming to that of the forward face of the pusher
60. At rest, the spring stop 96 is biased into the ejection track
70 and takes the position illustrated in phantom in FIG. 11.
The operation of the fail-safe mechanism embodied in the inventive
cartridge is as follows. With the jaws of the cartridge closed and
the plunger 76 activated, the pusher 60 advances in the direction
illustrated by arrow 102 of FIG. 11. The pusher freely advances
until contact is made with the rear face of the forwardmost staple
66 which, as shown in FIG. 11, lies in the ejection track 70. Then,
the pusher 60 advances the forwardmost staple 66 until the bridge
104 thereof contacts the cup-shaped extension 100 of the spring
stop 96. While the staple 66 advances, its bridge 104 cams the
extension 100 out of the ejection track 70 and into the position
illustrated in solid lines in FIG. 11. The pusher 60 continues its
forward journey until the staple 66 is ejected from the cartridge
and formed about the "bleeder."
In the event that the cartridge 30 is void of staples, of if a
staple is out of alignment in the cartridge, the operation of the
inventive hemostat-cartridge combination is varied. Under such
circumstances, the pusher 60 is prevented from making its full
forward thrust, and is hence prevented from contacting and injuring
the "bleeder" clamped between the jaws of the hemostat. Without the
action of a staple camming the cup-shaped projection 100 of the
spring stop 96 out of the ejection track 70, the forward face of
the pusher 60 is captured by the projection 100. In the absence of
a staple in the ejection track, the spring stop 96 remains in the
position illustrated in phantom in FIG. 11. Accordingly, the
inventive fail-safe mechanism ensures that the pusher 60 is blocked
from the "bleeder" 80 in all circumstances except when the
cartridge houses a properly aligned staple in the ejection
track.
The foregoing description and drawings have been presented for
illustrative purposes only and are not intended to limit the
present invention in any way. All reasonable modifications not
specifically set forth are intended to be included within the scope
of the present invention which is to be limited only by the
following claims.
* * * * *