U.S. patent number 3,638,653 [Application Number 04/846,566] was granted by the patent office on 1972-02-01 for suturing device.
Invention is credited to H. Lee Berry.
United States Patent |
3,638,653 |
Berry |
February 1, 1972 |
SUTURING DEVICE
Abstract
A combination of elements for use in surgery, particularly
suturing. The combination includes a conventional needle holder
with a second element, namely a needle-suture assembly combining a
suture storage chamber and a hollow needle through which the suture
is drawn. The needle-suture assembly is associated with the needle
holder in order that suturing is accomplished by manipulation of
the handles of the needle holder. The needle-suture assembly is
attached to the needle holder by grasping the needle with the
needle holder and also by means associated with the suture storage
chamber, which attaches the unit to the needle holder on the
opposite side of the pivot point from the needle. The latter
attaching means serves also to effectively lock the needle holder
against inadvertent opening during the suturing operation. The
suture storage chamber includes a storage spool which serves to
seal the storage chamber, store the thread, and to restrain the
suture against rapid, undesirable dispensing.
Inventors: |
Berry; H. Lee (McLean, VA) |
Family
ID: |
25298300 |
Appl.
No.: |
04/846,566 |
Filed: |
July 31, 1969 |
Current U.S.
Class: |
606/146;
112/80.05; 223/104; 112/169 |
Current CPC
Class: |
A61B
17/04 (20130101); A61B 2017/0496 (20130101) |
Current International
Class: |
A61B
17/04 (20060101); A61b 017/06 (); A61l 017/02 ();
D05b 001/00 () |
Field of
Search: |
;112/80,169 ;128/339,340
;223/103,104 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Pace; Channing L.
Claims
What is claimed is:
1. A suturing tool comprising the combination of a needle holder
and a suture storage-hollow needle assembly, the said needle holder
comprising a pair of pivotally mounted shanks providing means on
one side of the pivot point for grasping the said hollow needle,
and finger holding means on the opposite side of the pivot point
and at the ends of said shanks; additional means releasably locking
said shanks against pivotal movement in the area of said finger
holds; said suture storage-hollow needle assembly comprising a
suture material storage chamber, means in said chamber for holding
said suture material in position for unreeling, and means for
imposing tension during such unreeling; a suture material
passageway from said chamber; a hollow needle connecting with said
passageway, said needle being bent to an angle such as to afford a
point for grasping by said shank ends, and bent again beyond said
point to provide an arcuate working needle portion; means locking
said shanks against pivotal movement and for holding said assembly
in position relative to said shanks when the parts are associated
together for suturing.
Description
This invention relates to surgical equipment, more particularly, a
suturing device affording a number of advantages in presently known
suturing technique. The invention involves a combination of
elements including what is known as a needle holder and an
interrelated needle-suture assembly providing a hollow needle,
i.e., a tubular structure in which the suture material passes thru
the interior tube from its threading end to its working end, and a
suture supply chamber, both of which parts in normal association
are joined as a single unit. The needle holder, an old, reliable
and much used tool is a tonglike device designed for hand
manipulation by the surgeon in using conventional swage-suture and
other type needles, the "threaded" needle being clamped in the
working tongs and held securely by lock means at the hand holding
end which is provided with finger holds by which the tool is
manipulated. The needle-suture assembly is especially constructed
and adapted for association with the needle holder tool such that,
in association, the two pieces effectively become a single
instrument, highly suited to the deeply time-engendered motion
habits of the surgeon, which are almost as much a part of his
acquired surgical discipline as is his knowing of it. It is this
aspect of surgeon-compatibility, among the overall and several
other contributions of the invention, which imparts the fundamental
requirement of meaningful utility in the real and working world of
modern surgery; for unless a new device arriving in the field of
surgical instruments readily integrates itself with the thought and
motion reactions of the practicing surgeon-user, it may be and
often is condemned, even though the device may have real merit as
viewed in the abstract. This advantage of the present device and
aspect of the invention will be remarked upon more fully
hereinafter.
A second major advantage deriving from this invention involves
basic economics. This invention has the potential for substantial
saving of money. Wound closing and similar type of suturing
involves the use of needles which are costly, almost unimaginably
so considering the fact that they are merely small steel shafts. In
the swage-type suture needle, the cost arises primarily from the
difficulty of providing the special suture receiving aperture in
the needle. A very large percentage of operations are performed
with this type of needle and such percentage is on the increase.
These needles are provided with a tiny axial opening at the
threading end into which the suture is inserted in an axial
direction and then clamped fast therein by swaging the outer
surface down upon the suture. Such needles must be more carefully
made in order that the suture will be surely held so as not to pull
free in the course of the closing operation. Several such needles
are usually employed in a single major operation, and of course
they are not reused. Because of these two facts, i.e., basic needle
cost and the number needed, the cost added to a single operation is
substantial. The present invention affords a saving in money of
substantial magnitude. More specifically, the needle suture
assembly of this invention is produced according to the general
technique of hypodermic needle manufacture. Such devices are
producible at a cost of only a few pennies each; moreover, a single
needle-suture assembly is all that would normally be needed for a
single closing, whereas several are used in the case of the costly
swage type. As aforesaid, the needle-suture assembly constructed
according to this invention involves practically no loss in
discarding the entire assembly following the operation.
A third and most important advantage of this invention involves
saving of surgeon and surgeon-team time during an operation. Major
operations involve at least five professionals including two
surgeons, an anesthetist and two nurses for the entire time of the
operation. Moreover, and as will be appreciated, a saving in such
professionals' time inherently affords a saving in operating room
time and equipment use. Modern medical costs being what they are,
even a small saving of time is notable. It is estimated that the
present invention can reduce closing time of a wound layer as much
as 50 percent. Moreover, the patient may be returned to the
recovery room correspondingly sooner with notable physiological
benefits. The time saving factor flowing from the use of the device
of the invention resides in its capabilities for more rapid
suturing by the surgeon. Such is difficult to describe because of
the fact that, for full appreciation, one must envision the
substantial entirety of the manipulatory steps involved in present
methods in contrast to those permitted by this invention. In
general, the time saving accrues by reason of the fact that the
device of the invention is continuously useable for suturing
without the necessity for release of the needle-suture assembly
from the needle holder and subsequent regraspings as successive
stitches are made. This is in contrast to the technique necessarily
employed in using the present needles which, following thrusting
thru the skin layers, must be released and then grasped by the
needle holder on the emergent side and pulled thru. The suture is
usually tied at this point and tied by instrument in order to use
as small an amount of suture as possible. Tying by instrument is
usually considerably slower than tying by hand. Next, the needle is
regrasped by the needle holder for proper positioning in making the
succeeding stitching. This is time consuming and very
troublesome.
A further feature of the device is that it includes means which
serve the dual purpose of (1 ) secure locking of the holder against
accidental and reflex release during use, and (2 ) effecting secure
attachment of the needle-suture assembly to the needle holder. As
indicated above, once the needle-suture assembly is associated with
the holder, it is not necessary to alter the relationship until the
wound layer closing step is completed.
A still further feature is that the needle-holder assembly,
comprising the needle and suture storage portion, is constructed
such that it bears a size relationship to the needle holder which
offers no obstruction to manipulation of this device, which is in
wide and current use, and it does not add significantly to
weight.
Still further, the needle-suture assembly solves the problem of
suture tension in a highly simple and economical manner in that the
suture "spool" constitutes the tensioning means whereby the device
may be employed with the preferred facility without experiencing
the unreeling or pulling out of unduly long lengths of suture
material. To function with maximum facility and speed, tension must
be applied to hold back the unreeling of the suture from the spool.
The tension on the thread as imposed by the bobbin device should be
greater than the tension or frictional hold on the suture by the
tissue as it is left in place following needle insertion. The
understanding of this phenomenon is obvious when seen, but
difficult in explanation. The placing of a single suture involves
the following steps.
1. Penetration of the hollow needle loaded with thread through both
sides of the wound to be closed;
2. Grasping the thread as it emerges taut within the arc of the
emerging needle; the emerging thread may be grasped with fingers,
instrument, or penetrated with a blunt instrument with equal
facility, and the loose end of the suture thus pulled out from the
wound.
To perform this motion properly a tension must be applied on the
thread to unreel it properly and, at the same time, to cause the
end of the suture to emerge from the wound. Without tension on the
reel the reel unwinds too freely and gives no assistance or "back
pull" on the suture planted in the wound. In that event the end of
the suture must be manually pulled from the wound which takes time,
and is therefore undesirable.
3. The third step in the placing of a suture is to cut the suture
free and to tie the opposite ends.
In cutting the suture thread free from the thread source, a
convenient length of suture is left on both sides of the wound.
These ends may then be rapidly and easily hand tied or the ends may
be grasped and locked by a hemostat for later tying.
Although combined hollow needle-suture storage devices have
heretofore been known relating the needle and its suture supply
similarly, such are not adapted to the objectives of this
invention. Heretofore such devices have been designed for separate
hand manipulation as such, i.e., without relation to a needle
holder. The combination of the present invention has not heretofore
been provided or recognized as feasible. such known devices have
been provided with their own rodlike handle and thus intended for
separate employment. Accordingly, they have not satisfied the
demands of surgeons accustomed to using needle holders. Since prior
devices have been designed for use as an independent working tool,
they have involved expensive construction and large amounts of
expensive surgical material, hopefully permitting sterilization and
reuse, and therefore not affording the advantage of low cost and
disposability after a single use.
The invention is illustrated by drawings wherein:
FIG. 1 is an elevational view showing the thread storage-needle
assembly mounted in relation to the needle holder;
FIG. 2 is a view similar to FIG. 1 except that the device is
rotated 90.degree. thus providing a side view;
FIG. 3 is an end view of FIG. 1;
FIG. 4 is a showing of the thread storage-needle assembly partly in
section;
FIG. 5 is a sectional view taken on the line 5--5 of FIG. 1.
All of the drawings are enlarged as compared with normal instrument
size, FIGS. 1 and 2 being about 11/2 times normal and FIG. 3 being
twice normal size.
Referring to the drawings, numeral 10 denotes a needle holder of
the conventional type comprising two shank members 12 and 14,
pivotally joined as at 16 and affording clamping jaws 18 and finger
holding means 20. The holder is equipped with the usual
press-to-release locking means.
Numeral 22 denotes the needle-suture supply assembly comprising a
hollow needle 24, suture material 26 being shown issuing from the
working end of the needle. Numeral 28 denotes a coupling element,
firmly affixed to the hollow needle, serving to join the needle to
the suture supply chamber 30, the latter having an extending nipple
32 which is received within the hollow of coupling 28. The
engagement and holding of these joining parts is preferably
strongly frictional, thereby allowing ease of assembly and relative
ease in disassembly. The coupling and chamber unit 30 are suitably
of plastic materials, for example, a polyolefin, such as
polypropylene, or a polystyrene, many suitable materials being well
known. As will be seen, nipple 32 has a passageway 34 through which
the suture material passes to the needle. Supply chamber 30 is a
cylindrical body approximately 2 inches in length and three-eighths
inch or so in outer diameter affording a hollow interior for
containing suture material as mentioned above. Chamber 30 is of any
suitable low-cost plastic, although as will be understood it and
all related parts of the entire device are either sterile as
formed, or sterilizable prior to assembly and use.
A supply of the suture material 26 is shown wound upon suture
holder 33, the latter serving also to seal the chamber as at
numeral 35 and to provide a means for tensioning the suture against
overrunning. The tensioning means is denoted by numeral 36, it
comprising a circular body, or disc, occupying substantially the
entire inner lateral cross section of the chamber, much the same as
does the plunger element of the ordinary hypodermic needle. The
entire unit comprising the closure element, the suture holding
portion and the tension means preferably are of one-piece piece
construction and are of a relatively hard but somewhat resilient
material such as rubber. Various synthetic materials may be
employed also, as will be apparent.
As will be observed the suture material passes between the outer
periphery of the tensioning means 36 and the inner circumference of
the chamber 30. Thus, the suture material is well restrained; yet
by reason of the resiliency of the means 36, it is readily released
and pullable under moderate force.
It will be noted that the body of the thread storage holding
portion is tapered along its length, as in FIG. 4. The taper is
significant and important to suture flow, or running. It has been
found that a strictly cylindrical body, which results in an outer
cylindrical winding along the length, leads to difficulty in suture
material being readily pullable axially and downwardly therefrom,
the suture tending to hang up and be hard to pull, or to release
nonuniformly, i.e., at times under normal pull force and at times
only with strong pulling. Such tends to destroy the smoothness and
rhythm of use of the device. It can also interfere with the ready
withdrawal of the needle from the suturing step following its
initial delivery of the suture across the opening to be closed.
Numeral 38 denotes a member designed primarily to serve as a
positive overlock of the needle holder shanks against opening and
consequent needle release during the suturing operations. As is
known, the needle holder jaws are locked during use, but they are
releaseable merely by moderate squeezing of the finger grips,
whereby the necessary normally high pressure on the held needle is
released, and the needle and holder are separable. It occurs
occasionally in closing an incision that such separation is by
accident, which is quite disconcerting to a rapidly working
surgeon. However, more importantly as regards this invention, it is
a necessity, and thus the long established practice, in suturing
with needles which require that the needle and the holder be
separated in order to permit the inserted needle to be drawn thru
and across the body tissue, to squeeze the holder immediately so as
to bring it to unlocked position and draw it away from the needle.
This is a matter of reflex conditioning of the surgeon and the step
is automatic, substantially without contemplation. It is found in
the present invention important to guard against both such
accidental and reflex release; otherwise the suturing operation
will be interfered with to such an extent that the device may not
be considered to be compatible with surgeon psychology. This
locking member also serves to hold the needle-suture storage
assembly in fixed position along the shanks of the needle holder.
To these ends, member 38 includes a suitably formed firm, but
somewhat resilient metal piece, though it may be of any suitable
material, fashioned to provide a channel portion 40 adapted to fit
over the shanks of the holder 10 and slide thereupon to a point
where heavy bias is imposed against shank pivotal release, and a
channel 42 generally conforming to the cylinder shape of the
chamber 30. As will be appreciated, the member needs to be formed
with channel dimension such as to effect the desired locking before
it overslides the length of chamber 30. The grip of channel 40
should be such as not to permit loss of its position except by
deliberate manual release, this in order to avoid slipping along
the shanks while in use. The channel 42 preferably involves little
or no frictional bearing since the function is merely to reasonably
stabilize chamber 30 in the general direction of the body of the
needle holder.
As will be observed from an examination of the drawings, the hollow
needle 24 is shaped to relate the working end of the needle to the
needle holder in a fashion such that it has the desired direction
for use in suturing. Thus, the needle is bent at an angle of
approximately 90.degree. to provide a short segment 44 serving as a
gripping point for the needle holder. The segment of the needle
constituting the working part is shaped to provide a curved segment
46 having a general direction which is perpendicular to the axis of
the main shank portion of the needle which carries the coupling
portion 28, and also to segment 44. The direction of the curved
segment 46 relatively to the needle holder when the needle-suture
assembly is being held in position for working is upward, that is
to say, when the components are assembled and they are held in the
fingers in the normal position, the point of the needle extends to
a point well above the gripping tongs, the needle-suture storage
assembly being affixed on the right side of the needle holder.
It will be observed that the overall length of the needle-suture
storage assembly is not more than about three-fourths of the length
of the entire needle holder device. Therefore, it in no way
interferes with the manipulation of the assembly according to the
normal manipulation of the holder absent the assembly. As will be
appreciated, the hollow needle may provide a shank portion
corresponding to that denoted by numeral 48 in the drawings of any
desired length. The shank portion need be only long enough to
provide a connecting portion for coupling with the nipple 32.
Moreover, nipple 32 may be of any desired length to accommodate the
coupling arrangement, while permitting location of the chamber
itself along the shanks of the needle holder as desired. Further,
since the diameter of the chamber 30 is quite small, not
necessarily more than three-eighths of an inch or so, it offers no
obstruction to use of the device, and, in fact it actually
contributes to the comfortable holding of the combination in that
the forefinger of the holding hand is provided with a body, i.e.,
the chamber, to surround and grip. From this it will be appreciated
that the length of the needle-suture storage assembly relative to
the needle holder is not highly critical, but it is important that
the assembly be of relatively small dimension so that it can offer
no obstruction to the free handling of the needle holder in the
normal manner. Of course, the assembly is extremely light in
weight, less than an ounce as supplied for actual use.
In assembling the needle and suture storage portions of the
assembly and threading the needle, the needle is detached from the
nipple, the thread is delivered through chamber and nipple and then
through the hollow of the needle, a few inches being drawn beyond
the point of the needle. The thread holding body is then pushed
into the chamber 30 to the point where the closure portion thereof
fits tightly within the end of the chamber.
The needle-suture storage assembly is then clamped in working
position along the shanks of the holder and the member 38 is pushed
into position for locking the shanks. The device is then ready for
use.
The suturing is accomplished by thrusting the needle through the
tissue portion to be closed. As will be understood, a cord of
suture extends from the point of the needle to the tissue which is
then grasped by a tool similar to the needle holder 10 and the
remaining suture is drawn through the tissue, while simultaneously
withdrawing the needle back to the opposite side of the incision.
In this manipulation of the device sufficient length of suture
material is pulled from storage that the stitch can be tied in the
usual manner. The excess suture material is cut away and a few
inches of additional suture material are pulled from storage for
the succeeding stitch.
* * * * *