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.

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.

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.