U.S. patent number 3,580,313 [Application Number 04/789,474] was granted by the patent office on 1971-05-25 for surgical instrument.
Invention is credited to Charles Allen McKnight.
United States Patent |
3,580,313 |
McKnight |
May 25, 1971 |
SURGICAL INSTRUMENT
Abstract
A surgical instrument including particularly a stapling-type
instrument for attaching or anchoring fleshy parts of the body to
adjacent bone structure including means to facilitate such
attachments in areas of the body that are relatively inaccessible
and difficult to operate in.
Inventors: |
McKnight; Charles Allen (Little
Rock, AR) |
Family
ID: |
25147754 |
Appl.
No.: |
04/789,474 |
Filed: |
January 7, 1969 |
Current U.S.
Class: |
606/75 |
Current CPC
Class: |
A61B
17/10 (20130101); A61B 17/0642 (20130101); A61B
17/42 (20130101) |
Current International
Class: |
A61B
17/03 (20060101); A61B 17/10 (20060101); A61B
17/42 (20060101); A61B 17/064 (20060101); B25c
003/00 () |
Field of
Search: |
;227/19,140,156 ;145/46
;85/49 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Custer, Jr.; Granville Y.
Claims
What I claim is:
1. An instrument for implanting staples having integral head and
leg portions into bone and like structures comprising an elongated
body having portions thereof that are acutely angularly related, a
handle on one end of one of said body portions and an operative
portion on one end of the angularly related other body portion such
that the handle and operative portions are positioned in spaced and
opposed relationship, a groove formed in the operative portion on a
side thereof that faces the handle portion, said groove being
shaped to cooperatively engage the head portion of the staple.
2. The instrument defined in claim 1 wherein said operative
instrument portion includes a surface formed about said groove,
said surface being in opposed relationship to the handle portion
such that pulling force applied to the handle portion acts through
the elongated body in a direction that is substantially
perpendicular to said surface.
3. The instrument defined in claim 1 wherein said groove has a
first groove surface positioned to engage and support the head
portion of a staple to be implanted.
4. The instrument defined in claim 3 wherein said groove has end
wall portions adapted to engage the staple legs adjacent to the
head portion thereof to retain and support a staple positioned in
the groove.
5. The instrument defined in claim 4 wherein the groove end walls
are spaced apart a distance such that they exert force against the
leg portions of a staple positioned in the groove in a direction to
maintain the staple in the groove during implantation thereof in
bone structure.
6. Means for fastening portions of living body tissue to adjacent
bone structure by forcing a U-shaped staple through the tissue and
into the bone structure, said means comprising an instrument for
use in forcing said staples through the living body tissue and into
bone structure, said instrument including spaced handle and
operator portions and means including an elongated instrument body
having angularly related portions connected respectively at
opposite ends thereof to said handle and operator portions to
maintain said portions in fixed spaced relationship, said operator
portion including an anvil member having a surface thereon in
spaced opposed relationship and in substantial alignment with the
handle portion, and an elongated groove formed in said anvil member
adjacent to said surface, said groove being constructed to
cooperatively engage and support a staple while the staple is being
forced through the body tissue and into the bone structure by force
applied on the handle portion in a direction away from but
substantially in alignment with the operator portion of the
instrument.
7. The means defined in claim 6 wherein the groove in the operator
portion of said instrument is defined by spaced side and end walls
constructed to cooperatively engage the staple and to prevent
relative movement between the instrument and the staple during the
time when the staple is forced into the bone structure.
8. The means defined in claim 7 wherein the groove is constructed
so that the staple must undergo stress to be moved to a fully
seated position therein.
9. Means for fastening tissue to adjacent bone structure in a
living body for forcing a staple of substantially U-shape including
integral head and leg portions through the tissue and into the bone
structure, said means comprising an instrument for installing the
staple in a living body, said instrument having a first portion
including means constructed to retain and support the staple during
installation thereof, and a second portion spaced from and
connected to the first portion and including a handle portion, and
means connecting the handle portion to the first portion, said
first portion including a member having a surface facing the handle
portion and a groove formed in said surface, said groove being
defined by opposed side and end walls and a bottom wall extending
therebetween, said groove end walls being spaced closer together
than the unstressed staple leg portions adjacent to the head
portion thereof so that the staple leg portions must be forced
closer together than they are in their unstressed condition to
install the head portion of the staple in the groove in a fully
seated condition in which the head portion abuts the bottom wall of
the groove.
10. The means defined in claim 9 wherein said first instrument
portion includes a second groove positioned adjacent the aforesaid
groove, said second groove being shallower than the aforesaid
groove so that it can be used to engage the head portion of a
staple that has been partially pressed into bone structure during
completion of the pressing in of the staple in the bone structure
to the desired depth.
11. Means for use in female surgical procedures to staple tissue to
adjacent bone structure to correct certain female disorders caused
by insufficient or poor support of the urethra and bladder neck by
providing support therefor, the means being used to force a staple
member of generally U-shape through the tissue and into the bone
structure, said means comprising an instrument for implanting said
staple through body tissue into adjacent bone structure, said
instrument having an operator portion, a handle portion, and means
including an elongated member connecting the handle portion to the
operator portion in spaced and opposed relationship to each other,
said operator portion having a surface formed thereon in generally
opposed spaced relationship to the handle portion, a slot formed
extending inwardly from said surface for supporting a staple during
implantation thereof, said slot being defined by a bottom wall and
adjacent spaced end and sidewall portions, the bottom wall of said
slot being generally parallel to the said surface and said side and
end walls having portions oriented substantially perpendicular to
said surface for engaging and supporting portions of a staple
positioned therein, said surface being adapted to be moved into
contact with an area of the body tissue which is being attached to
the adjacent bone structure during implantation of a staple to
limit the penetration of the staple into the bone structure when
pressure is applied through the handle portion to the staple
positioned in the slot.
12. The means defined in claim 11 wherein the construction of the
slot is such that the staple must undergo some stress and change in
shape to be positioned therein.
13. The means defined in claim 11 wherein said slot is constructed
to frictionally engage and support the staple.
Description
It has been found that certain types of medical conditions can be
helped by attaching fleshy portions of the body to the adjacent
bone structure. This is especially true of certain kinds of
conditions including particularly conditions that occur in females
as an after effect of childbearing such as stress incontinence and
for certain types of congenital defects, and for some conditions
that result from certain types of injuries as well. Stress
incontinence is one of those conditions that may occur in females
after they have passed their childbearing years, particularly when
they have had a number of children. Such females develop a
condition where the bladder tends to sag and move away from its
normal position against the interior pubic bones causing urine
leakage, discomfort and embarrassment and in some instances
infections of the urinary tract may also develop. In the past,
these stress incontinence conditions have been relieved to some
extent and with varying degrees of success by anterior vaginal
repairs where meticulous attention is paid to the repair of the
supports at the neck of he bladder. Special surgical procedures
have also been devised, each having the common purpose of elevating
the bladder neck and creating a suitable vesicourethral angle.
These procedures are difficult and time consuming to perform and
often have included the construction of a fascial sling or other
vesicourethral suspension means. Such procedures may involve danger
to some patients and are further complicated by the fact that they
must be performed in areas or cavities of the body where space and
access are extremely limited.
The present invention which is useful, among other things to
correct stress incontinence is embodied in a relatively simple and
easy to use instrument which is constructed so that it can be
accurately controlled and manipulated for locating and forcing
staples through body tissues into the adjacent bone structure to
anchor the flesh thereto even in areas of limited space such as
from a position that is accessible by entry through the mouth or
other portion of the female vagina. The subject instrument is
designed so that it can be used by a surgeon or other person to
staple flesh to bone structure in places where it is inconvenient
or impossible to see the operation as it is being performed and
where the surgeon must rely on locating the parts including the
body parts and the anchoring means by feel along. To this end the
subject device includes means for supporting a fastener such as a
staple or staplelike device while aiming or locating it in position
to be driven, and means on the instrument by which controllable
force can be brought to bear on the staple to drive it into a final
fixed position in a patient's bone structure to anchor adjacent
flesh thereto. In an actual operation this may include stapling
tissue across a sagging portion of a bladder adjacent to the
urethral orifice in a female to elevate the posterior urethra and
to maintain the neck of the bladder in a normal or nearly normal
position against the pubic bones. The present invention enables
this type of repair to be accomplished in a minimum of time and
with minimum of pain and expense to the patient. The operation is
also relatively easy to perform especially when compared to other
known operations and procedures used to correct the same condition.
Furthermore, the results of tests using the present device and
procedure indicates a relatively high possibility for success. It
is also noteworthy that the subject instruments are relatively
simple to make and use, they preferably have no moving parts, they
are easily cleaned and sterilized, and relatively little training
is required to master their use. Furthermore, a minimum of advanced
preparation is required by the surgeon using the subject instrument
thereby simplifying the surgical procedures and reducing the
discomfort to the patient. Although the subject invention has
special application for performing the above type of repair, it is
anticipated that it will also have many other uses and applications
including any application where it is desired to perform stapling
operations in limited access and out-of-sight areas as for example
in making rectal and genital repairs, organ transplants, and
cosmetic repairs to name a few.
It is therefore a principal object of the present invention to
provide simple and easy to operate means for attaching or anchoring
tissue to adjacent bone structure.
Another important object is to provide means for attaching flesh to
bone structure by a stapling operation.
Another object is to provide a stapling-type surgical instrument
that is constructed to be used in relatively inaccessible regions
of the body.
Another object is to provide means by which it is possible to
accurately locate and seat a staple in bone structure or the like
without being able to see to locate and drive the staple.
Another object is to provide a relatively simple and inexpensive
one-piece surgical stapling instrument.
Another object is to provide similar one-piece instruments for
locating and initially seating a staple and for thereafter
completing the driving of the staple or staplelike device to a
predetermined depth into a bone structure particularly at a
location that is not readily accessible or visible to the one
performing the stapling operations.
Another object is to provide a staplelike fastener particularly
constructed to be used to fasten flesh to adjacent bone
structure.
Another object is to provide a surgical instrument which requires
relatively little training and skill to use.
Another object is to provide a surgical instrument that is
relatively easy to clean and sterilize.
Another object is to simplify the surgical procedure necessary for
relieving or curing stress incontinence and like conditions.
These and other objects and advantages of the present invention
will become apparent after considering the following detailed
specification which covers several preferred embodiments thereof in
conjunction with the accompanying drawings, wherein:
FIG. 1 is a perspective view of a surgical instrument constructed
according to the teachings of the present invention;
FIG. 2 is an enlarged top view of the head portion of the
instrument of FIG. 1;
FIG. 3 is an enlarged cross-sectional view of the head portion of
the subject instrument taken on line 3--3 of FIG. 2, said head
portion being shown with a staple positioned therein;
FIG. 4 is a cross-sectional view taken on line 4-4 of FIG. 2 and
showing the subject device in operative position after a staple has
been driven into bone structure;
FIG. 5 is an enlarged side view showing an unstressed staple for
use with the instrument of FIGS. 1--4;
FIG. 6 is an enlarged top view similar to FIG. 2 but showing a
modified form of the subject instrument; and,
FIG. 7 is a view showing the subject instrument in operative
position extending part way into a female vagina after preliminary
surgical preparations have been made, said instrument shown being
used to attach a portion of the paraurethral fibrous tissue to the
adjacent posterior aspect of the pubic bone to support the bladder
and urethra in positions to overcome or cure a condition of stress
incontinence.
Referring to the drawing more particularly by reference numbers,
number 10 refers to a surgical instrument constructed according to
the teachings of the present invention. The instrument 10 can be
constructed from any of a number of materials and is preferably of
one-piece construction. The instrument 10 includes a handle portion
12, an operator or head portion 14, and means including a
connecting portion 16 extending therebetween. In the form shown the
connecting portion 16 is an elongated member that includes acutely
angularly related portions 16a and 16b.
The operator or head portion 14 of the instrument 10 is shown
formed on the free end of the portion 16b and includes a surface 18
positioned in opposed spaced relationship to the handle 12. In the
form of the instrument shown in FIG. 2, two spaced grooves or slots
20 and 22 are formed in the surface 18 of the head portion 14. One
of the grooves, shown as the groove 20 in FIG. 3, is relatively
deeper than the groove 22 and is defined by a bottom surface 24 and
two spaced parallel or nearly parallel end surfaces 26 and 28. The
groove 20 is designed and shaped to receive and support a staple
such as U-shaped staple 30 shown in FIGS. 3 and 5. The staple 30 is
shown in its unstressed condition in FIG. 5 and is defined by two
spaced leg portions 32 and 34 and an integral connecting portion
36. The legs 32 and 34 in the unstressed condition of the staple
are preferably not parallel to each other but instead are further
from each other at their free ends than at their connected ends.
This is done so that some force must be applied on the free ends to
enable the staple to be positioned in the groove 20 as shown in
FIG. 3, and to enable the groove 20 to hold and support the staple
30 without requiring any other holding and supporting means. The
groove 20 is therefore used to hold and support the staple 30 while
the staple is being set in position and forced into place as will
be explained. In the preferred form of the device the staple is
also made of some hard corrosive resistant material such as
stainless steel, and the free ends of the legs 32 and 34 are
preferably sharpened to fine points to make it relatively easy to
drive the staple into bone structure or the like. It is also to be
noted that in the stressed condition of the staple which is the
condition shown in FIG. 3, the leg portions 32 and 34 are parallel
or nearly parallel and this is the condition in which it is driven
into the bone structure. Therefore, the legs will exert some
sidewise pressure after it is installed to help hold it in place.
However, the groove 20 (FIGS. 2 and 3) may be too deep to permit
the staple to be fully or even sufficiently seated while positioned
therein to prevent looseness in the attachment being made, and for
this reason the second shallower groove 22 is included to provide
means to complete the seating of the staple to its desired final
position. It is also contemplated to make the staple legs 32 and 34
parallel and to form the end surfaces or walls 26 and 28 of the
groove 20 so as to frictionally engage and hold the staple without
having to stress the legs.
The grooves 20 and 22 rather than being formed in one single
instrument as shown in FIG. 2, may also be formed in two separate
similar instruments as illustrated in FIG. 6 which shows an
instrument 10' having a single groove 22'. Having two similar
instruments instead of one with two grooves may have advantages
particularly when a doctor might have a difficult time being sure
that he has positioned the staple in the proper groove especially
in the shallower groove 22 used to complete the driving of the
staple to the final desired position.
The subject instruments 10 and 10' are designed primarily as
surgical instruments to be used in female surgery for anchoring the
bladder to the adjacent bone structure, as already stated. To
accomplish this the operating or head portion 14 thereof with a
staple 30 in groove 20 is positioned extending in through a portion
of the vagina of the female patient as clearly shown in FIG. 7.
Before reaching this stage of the procedure, however, it is usually
necessary for the doctor to have prepared one or more places for
locating the subject staples which preparation will usually involve
some minor surgery. The procedures for doing this are not part of
this invention. Thereafter, and with the instrument in operative
position as shown, the surgeon will use the fingers on one of this
hands to guide and locate the pointed ends of the staples and also
to prevent the pointed staple ends from causing unwanted injury to
other tissues in the area. When the staple ends are properly
located, the surgeon will apply force with his other hand on the
handle portion 12 in a generally upwardly direction to force the
staple through the tissue and into the bone structure. He is able
to do this with considerable force and good control because of the
leverage provided by the shape of the instrument and by the fact
that he is pulling the instrument in a direction generally toward
his body. After the staple has been driven in as far as possible
using the deeper groove 20, it is an easy matter to free the
instrument from the staple, and again using his fingers to locate
the staple in the shallower groove 22, or 22' if a single groove
instrument is being used. He can now complete the driving and
seating of the staple to the desired final position. A typical
operation will usually involve the placing of two or more staples
in the manner described.
The staples 30 preferably have outwardly biased legs 32 and 34 as
aforesaid and are preferably constructed of some suitable material
that can be surgically sterilized and that can be tolerated by
living tissue. Stainless steel is one material that seems to offer
particular advantages in this regard. Many sizes and/or other
shapes for the staples other than those shown in the drawing are
also possible and contemplated including staples having relatively
wide flat head portions which offer some hope of providing even
better support for the tissue and perhaps even less chance for a
tear. Staples can also be constructed having other cross-sectional
shapes and the legs of the staples may have outward protuberances
37 at various positions to provide even better engagement with the
bone structure. As clearly shown in FIG. 4, the outward bias of the
staple legs 32 and 34 may also cause the free ends of the staple
legs to move apart slightly as the staple is driven into bone to
help hold it in position and to prevent it from coming out. In FIG.
4 this outward movement is shown exaggerated for clarity, since
only slight outward movement is anticipated as being desirable to
help maintain the staple 30 in the bone 38.
A more specific disclosure of the actual position of the subject
instrument in relation to the organs in a female during operation
thereon is shown in FIG. 7. In this showing the subject instrument
is being used to correct a female incontinence condition due to a
sagging bladder. In this case the patient is in a lying down faceup
position and the perineum is prepared as in any vaginal surgery. A
catheter 40 is placed in the bladder 42 so that undesirable flow of
urine can be controlled during the operative and the post operative
periods. An incision 44 is cut in each side of the anterior vaginal
wall 46 and an examination is made of the area around the bladder
42 by the surgeon inserting his fingers through the incisions to
locate the proper places for the staples. The doctor then takes a
staple 30 which has been previously sterilized, and presses the
free ends of the legs 32 and 34 together slightly to enable him to
insert the staple 30 into the groove 20 of the instrument 10 which
has also been sterilized. The normal outward bias of the legs 32
and 34 tends to hold the staple in the groove 20 as aforesaid. With
the staple 30 in the groove 20, the operator portion 14 of the
instrument 10 with the staple 30 positioned therein is carefully
inserted into the mouth of the vagina and the pointed ends of the
staple are located at the desired positions within one of the
incisions 44. The doctor then pulls the instrument 10 upwardly away
from the patient thereby driving the staple 30 through the
paraurethral tissue 48 and into the pubic bone 50. As the staple
passes into the pubic bone 50 there is a characteristic crepitant
sensation transmitted to the doctor through the instrument 10 which
allows the doctor to feel the progress of the staple 30. As can be
seen, the acute angle formed in the connecting portions 16a and 16b
of the instrument between the handle portion 12 and the operator
portion 14 is necessary to allow proper transfer of force to the
staple 30 in this awkward position.
Once the staple 30 is partially driven into the pubic bone 50, the
instrument 10 is released from the staple by tilting or other
movement and the shallower groove 22 is placed against the staple
and the operation repeated as before to complete the driving of the
staple. Thereafter the instrument 10 is withdrawn from the incision
44 and loaded with another staple and reinserted into the vagina as
before for locating and seating in the other previously made
incision by a repeat of the foregoing procedure. In this way, the
paraurethral tissue 48 is attached to the pubic bones 50 so that
the paraurethral tissue 48 forms a strap or sling across the
urethra 52 and across the neck of the bladder 42 to support them in
proper position against the pubic bones 50.
The procedure can be varied by using the instrument 10 (or 10') to
seat both staples initially and then completing the driving of the
staples as a second step. An estimated force of 15 to 20 pounds is
about the maximum that is usually necessary to seat and drive home
each staple. When both staples are properly in position, the
incisions 44 are reclosed.
The groove 22 or 22' can be made having different depths in
different instruments. As shown in FIG. 4, it is the depth of the
slot 22 or 22' into the surface 18 along with the resilience of the
tissue 54 being stapled which determines how deep into the bone 38
a staple 30 will ultimately be driven and hence how much space is
provided between the head 36 of the staple 30 and the bone 38.
There should always be a certain space between the head 36 of the
staple 30 and the bone 38 so that the stapled tissue 54 will have
adequate circulation and remain viable living tissue. The proper
size of this space depends on the type and thickness of the tissue.
Although the subject invention is primarily designed for the
operative procedures described above, by varying the angle of the
connecting portion 16 between the handle 12 and the operator
portion 14, and by changing the size and shapes of the staples and
their matching grooves in the instrument, it can be used for other
procedures as well including being used in rectal repairs, cosmetic
surgery and in certain types of transplants where it is desirable
to attach flesh or organs to bone structure.
Thus there has been shown and described a novel surgical instrument
which fulfills all of the objects and advantages sought therefor.
Many changes, modifications, variations, and other uses and
applications of the subject instrument will, however, become
apparent to those skilled in the art after considering this
specification and the accompanying drawing. All such changes,
modifications, variations, and other uses and applications of the
subject instrument which do not depart from the spirit and scope of
the invention are deemed to be covered by the invention which is
limited only by the claims which follow.
* * * * *