Retention Bar Means For Surgical Incision Closure

Abstract

For use in retaining a surgical incision against inadvertent rupture or disruption, a pair of retention bar elements which provides reinforcing means for the retention thread loops of an incision closure and provides means for reducing flesh tearing and necrosis at the thread loop penetrations of the skin and body tissue. The pair of retention bar elements are adapted to be located parallel and on opposite sides of the line of incision of a surgical wound and preferably are formed of pliable tear resistant material, such as extruded polyvinyl plastic material. A preferred form is generally of a figure of eight configuration as seen in transverse section so that each retention bar element includes parallel dual tubular portions connected by a thin web portion. In use of the retention bar elements of the invention, retention thread loops pass through the web portions of the pair of bars, extend transversely over the incision, and encircle the confrontingly extending tubular inner portions respectively of the retention bar elements, the bar providing purchase so that the forces uniting the loops and holding the incision are oriented away from the flesh surface and do not tear it, but rather the tearing forces are transferred to the bars, and the pliability of the material yields so as to conform to the flesh surface and distribute the load of the retention loops as the contour of the flesh surface changes during the healing process as swelling occurs and then diminishes.

Description

BACKGROUND OF THE INVENTION

Field of the Invention

This invention relates to surgical incision closure retention suture means generally and more particularly relates to retention bar elements for use in operating procedures for preventing elongation or eroding of skin and tissue at the thread loop penetrations and is designed to increase the effectiveness of retention loop sutures.

Description of the Prior Art

Although the use of heavy thread retention stitches or retention loop sutures have long been recognized as a principal means for safeguarding an incision against inadvertent disruption, the prior art techniques which use retention sutures have had certain undesirable effects resulting in use: since the retention loop must be drawn tautly across the incision and maintained in such condition for effectiveness, there is often a tendency of the thread loop to elongate or erode into the skin and tissue at the thread loop penetrations of the incision injuring it and resulting in skin necrosis and causing objectionable scar tissue of the wound after healing. Various devices have heretofore been employed to prevent such occurences and include the use of gauze padding, buttons, segments of rubber tubing, and plastic bridges. Such devices have as a principal purpose, to lift the retention suture thread loops away from the skin surface and to reinforce or distribute the cutting pressure of the thread loops over a wider area of the skin tissue at the suture perforations. While the use of gauze padding, buttons, and other such devices have been helpful in many applications in reducing the disadvantages referred to above generally, serious problems have remained. Also, as healing of the incision wound initiates in a normal process, it tends to swell being more apt to be damaged in this condition and the application of certain of the prior art retention loop reinforcing devices may hold the retention suture thread in a continuously taut and unyielding manner which further aggravates the tissue tearing tendency of the retention suture prior art ligation and does not provide structure which yields to adjust to such swelling as healing takes place, with the swelling gradually diminishing.

The retention bar means of the instant invention obviates many of the above-mentioned objectionable features noted in the use of the retention suture reinforcing devices of buttons, gauze padding, or the like, and provides an effective means for reducing the tissue cutting tendency of retention thread sutures by providing an effective means for spreading the thread pulling pressure over a wider area of the skin adjacent the thread loop penetrations; and, additionally, is easily applied. Also the use of the retention bar means of the invention reduces substantially the formation of objectionable scar tissue surrounding a healed wound, improving the cosmetics of the field or area of the operation and confining it, by reason of the fact that the improved retention bar elements of this invention permits the retention loops at their penetration in opposed relation with the flesh of the skin to be closer together. The retention bar means firmly retains the incision wound against disruption and yet permits yielding movement to accommodate normal swelling and permits controlled ligation of the wound during normal body movements of a patient or when undue stress is placed on the incision by coughing, sneezing, or other such occurences. The retention bar structure of the instant invention and its procedure of use, also admits of ready inspection or attendance to a surgical incision and effective postoperative procedure.

BRIEF DESCRIPTION OF THE DRAWING

FIG. 1 is an environmental view of the retention bar means of the instant invention in conjunction with a series of retention loop elements in a retention suture development closing an incision;

FIG. 2 is a perspective view of a preferred configuration of a retention bar element;

FIGS 3, 4, 5, 6 and 7 are alternative constructions of retention bar elements.

DESCRIPTION OF THE PREFERRED EMBODIMENT

The retention bar means of the instant invention is generally designated by numeral 12 in FIG. 1 and is shown and described in conjunction with a series of retention suture loop elements R providing postoperative retention means for a typical abdominal incision I. Generally, the procedure and particular configuration of the retention thread suture means of the drawing do not constitute a part of the invention; however, for illustrative purposes, the general method of suturing an incision is performed by placing incision sutures such as S1, S2, S3, in the manner shown. The retention bar elements of the present invention are designated by the numerals 14 and 14' and are used in reinforcing the series of retention thread sutures or loops.

Each of the retention bar elements 14 and 14' of the pair are preferably of like transverse design and companionate length and may be formed by severing a single length of retention bar stock material. For this reason, the following specific description of a preferred configuration of the left retention bar element 14 will suffice as to a description of the right retention bar element, which is also characteristic of the other embodiments which will also be discussed hereinafter.

The retention bar 14 is preferably formed of polyvinyl extruded plastic material of resilient or cushioning character. The polyvinyl material preferably is of a firm resilient constituency permitting resilient lateral deformation and longitudinal biaxial flexure of the bar. This illustrated retention bar 14 FIG. 2, is of a generally symmetrical figure eight transverse section and preferably includes parallel dual-arranged inner and outer rib portions 16 and 18 and a web portion 20 integrally connecting the rib portions in parallel longitudinally extending disposition. The inner and outer rib portions 16 and 18 of the retention bar element 14 preferably are respectively of tubular thin-wall ellipsoidal form and with the lateral axes of the element through the web being adapted to overlay the field in spaced relation above it when in a normal unstressed condition with the pair of elements aligned and on opposite sides of the incision line. The retention bar element 14 optionally may be provided with a series of thread apertures 26 uniformly intermittently arranged in spaced relation along the length of the web 20 of the retention bar. The thread apertures 26 may be formed during manufacture of the retention bar or optionally, the thread apertures may be formed during surgical procedure by the needle means used to form the retention thread ligation or network.

The retention bar elements 14 and 14' may be applied in a surgical procedure in the following manner: Prior to the closing of the incision, the several retention thread lengths are embeddedly placed transversely in the wound area and with the opposite free ends of the retention threads anchored as in conventional manner by hemostat and towel means. The several series of incision stitches S1, S2, S3 are applied to close the incision openings respectively of the several layers L1, L2, L3 of the abdomen wall structure. The pair of retention bar elements 14, and 14' are then located parallel and each respectively on opposite sides of the line of incision; the loose end portions respectively of the retention sutures R are passed upwardly through the web apertures 26 or by perforating the web portions respectively by the needle means of the retention sutures (the arrow 28 in FIG. 1 illustrates this step of the procedure).

The adjacent loose ends R1, R2 of each pair of retention sutures are tied together along the respective web portions 20, 20' , forming respectively the longitudinal ties T, T' (this step is indicated by arrow 30 in FIG. 1). At this state, an elongate padding of gauze material (not shown) may be placed over the incision and between the parallel retention bars. The double strand segments RR of each adjacent pair of retention sutures, are brought together and tied, forming the double strand retention ties RR (this step is indicated by arrow 32). The wound surface is now closed and with the several double strand cross sutures RR each being tied and tautly spanning the tubular inner rib portions 16, 16' of the pair of retention bars (indicated by arrow 34). To the extent that the area around the wound excessively swells, and at the first dressing change the transverse retention sutures RR may be cut to accommodate the swelling beyond that which is relatively normal. At this stage, the retention bar elements remain in position along the opposite side of the incision line being fastened to the flesh by the suture loop segments R passing transversely and being embedded in the flesh beneath the incision line and by virtue of the longitudinally spaced portions of the loops T and T' which are above the flesh surface and secured along the web portions 20 and 20' of the retention bars. The wound is held in a firm but relaxed disposition, and the gauze material may be removed and the wound attended to. After a period of 4 to 10 days, the pair of retention bars may be removed by clipping the retention sutures R underneath a respective one of the retention bars; clipping the thread from underneath one bar permits removal of that bar, and then the opposite bar may be lifted and removed, thereby withdrawing the series of embedded suture thread segments from the wound area.

While the embodiment of FIG. 2 illustrates a preferred configuration with each bar element being characterized by dual or parallel zones 56 and 58 for flesh contact, other configurations are suitable, it being pointed out, however, that the lower or flesh confronting surface generally designated by the numeral 66 is elevated as at 62, 64, 66, 68 and 70 by reason of the curvature of the lower surface, it is thus seen that the united ends of the loops passed beneath the incision are arranged such that the zone of contact with the flesh is somewhat adjustable as the curved surface of the zone gently nests over the flesh along opposite sides of the wound and does not bite into or present sharp edges so that as swelling occurs injury is not caused to it. Also, opposing united ends of the spaced loops embedded in the flesh when connected by the retention portions RR are oriented so that forces drawing the tied ends T and T' together are constrained by reason of the purchase obtained by the bar elements to forces at the skin surface and that the tendency of such forces to tear the flesh is transferred to the retention bar elements by reason of the configuration of them. The zone of contact is of an area which changes as swelling occurs in the field, that is, the pliable material of the bar elements as seen in cross section flexes downwardly to increase the zone of contact. Also, the axial length of the retention bar elements tends to conform to the surface of the flesh as swelling occurs and diminishes during the healing process, providing retention bar elements which while maintaining a purchase to resist tearing and consequent scarring, simultaneously yield to healing forces conforming to the changing contour of the flesh surface. It will be noted that as swelling occurs the zone of contact is increased, in the embodiment of FIGS. 2 and 3 particularly, and by so doing distributes the load over a wider area without significant effect on the purchase obtained by reason of the configuration of the retention bar element. Therefore, by reason of this invention, the field subjected to scarring may be reduced since the retention bar elements permit the retention sutures to be more closely spaced to the incision line causing a reduction in the field and consequently a reduction of the area which is cosmetically affected as well as improving the cosmetic appearance of it by reason of reducing the tear force effect on the flesh itself.

Referring to FIG. 3, an alternative embodiment is shown which comprises a pair of retention elements, each of which are similar and therefore only that designated by numeral 75 will be referred to in this paragraph. It includes a body 77 which is tubular and preferably of uniform cross section and generally ellipsoidal in form. It is provided with a longitudinally extending flange 79 which extends outwardly from the major axis of the tubular body 77 and which is adapted to receive the opposite ends of the retention loops referred to above along the region of juncture 81 between the flange and the body. This configuration is oriented in the manner indicated in FIG. 3 with respect to the incision line which is designated by the letter I. It is thus seen that by reason of the passage of the opposite end portions of the loops R through the region 81, a purchase is obtained at each thread loop by reason of the curvature of the upper surface 83 of the bar elements.

Referring to FIGS. 4 and 5, the retention bar elements are shown on opposite sides of an incision line again designated by the numeral I and are, in the case of FIG. 4, of generally circular section, while in the case of FIG. 5, are of generally elliptical section, the elements of FIG. 4 being designated generally by the numeral 86 and the elements of FIG. 5 being generally designated by the numeral 88. These elements are provided on opposite sides of the length of the incision and receive the ends of the loops R passing therethrough. While the embodiments of FIGS. 4 and 5 are tubular, that is provided with an extending column therethrough as at 89 and 90 respectively, in certain embodiments not shown, the same may be of solid configuration. By reason of the foregoing, it is seen that there is provided, in the embodiments shown in FIGS. 4 and 5, a thin walled deformable retention bar element which is adapted to yield to the forces of swelling and thread tautness in installation so as to present a lower surface having a zone of contact 92 and 94 to distribute the load while at the same time being of a sufficient height to cause a purchase or force orienting to resist tearing and transfer the thread forces to the retention element body. Also, the bar elements, configured as in FIGS. 4 and 5, are yieldable to vertical forces caused by swelling, and also by reason of the pliability of the material of which they are constructed, vary in contour along the axial length when installed, in response to swelling so as to uniformly distribute the thread pulling forces. The bar elements 86 and 88 each may be provided with a plurality of intermittently spaced thread apertures along the length thereof, corresponding in form and function with the thread apertures 26 in the embodiment of FIG. 1. While the bar elements 86 and 88 of the embodiments of FIGS. 4 and 5 are not as preferred as that of FIG. 2, by reason of the fact that there is an unfavorable contour presented to the flesh skin to accommodate swelling, the bar elements 86 and 88 each provide a zone of contact and force distribution and orienting means which is yieldable and in a sense floatable on the flesh surface in response to the adjustment required as swelling and healing processes occur. The utilization, however, of a retention bar element of dual-tube form, as shown in FIG. 2, is preferred since the orientation of such retention bar is fool-proof, which is not the case with respect to the retention bar embodiment of FIG. 3, the use of which requires the flanged portion 79 to be arranged outboard of the tubular body 77 and with respect to the incision line.

Referring to FIG. 6, there is shown a pair of spaced retention bar elements 100 and 102 which are aligned parallel to an incision line I and which are generally of the same tear resistant pliable material, in strip form and of a sufficient thickness 114 so as to provide purchase for the purposes described above while at the same time being yieldable to conform to the flesh surface. In the embodiment of FIG. 6, it is preferred that the longitudinal medial length of the oppositely oriented main surfaces 104 and 106 be recessed, defining longitudinal grooves 108 and 110 and a relatively thin web area 112 to accommodate passage of a needle used in the development of the sutures. In use, the thickness 114 of the retention elements 100 and 102, between the upper and lower surfaces 104 and 106, is such as to provide purchase in that the elongate symmetrical mass 116 on the inboard sides of the elements is sufficient to distribute the load along the opposite sides of the wound. In this embodiment, the longitudinally extending corner edges 118 preferably are somewhat rounded so as not to present sharp surfaces, and by reason of the cushioning material of construction, do not chaffe the skin surface.

The retention means described above provide a pair of elongate companionate retention bar elements adapted to be placed on the opposite sides of an incision with each of the elements being of a pliable tear resistant material, which are flexible with respect to the longitudinal axis and deformable with respect to the cross sectional areas. Each retention bar element preferably is formed to transparent surgical quality polyvinyl chloride, and extruded with a thin web or flange portion through which a needle is adapted to be passed and which is therefore penetratable by the same, and includes a purchase causing portion, compressible in cross sectional area, and which is of a height between the flesh abutting surface and the outer surface sufficient to cause a purchase effect orienting the retention sutures outwardly of the incision area. Also, each retention element is deformable to conform to the varying contour of the surface of the flesh and to follow the contour thereof as the healing process takes place, and in a sense to float to a degree generally conforming thereto.

In a preferred embodiment, the stitch receiving portion or plate of the elements is in the order of between 20 and 60 thousandths of an inch thick and in any event is sufficient to resist the tearing or slicing forces of the suture threads passing through the stitch receiving portion. The air columns of the hollow bar elements shown may be bounded by walls of varying thickness to achieve the results and purposes set forth herein and to define a stitch receiving portion and a purchase causing portion; and preferably the elements are all of flexible pliable tear resistant plastic material and of uniform cross section throughout their lengths. A thin recess or guide line designated by the numeral 115 in FIG. 4 and 117 in FIG. 5 may be provided to designate the stitch receiving portion in contradistinction to the purchase causing portion, this being achieved in FIGS. 2 and 6 by the longitudinally extending recesses formed in the exterior surface of the bar elements, and as by the crotch of the angle between the stitch plate or flange 79 and the body 77 of the element shown in FIG. 3. Additionally, color coding may be provided to designate various retention element lengths for selection of them from suitable storage facilities or to indicate the orientation of the stitch plate or the stitch receiving portion of the elements. The embodiment of FIG. 7, provided with the cite line 115' may also be used as an alternative embodiment.

Claims

What is claimed is:

1. For use in a surgical incision wound closure procedure wherein retention thread loop sutures are applied transversely of the incision area as a precautionary measure for preventing wound disruption, with a portion of the loop being embedded in the flesh beneath the incision line and a portion above the line and spanning the incision,

retention bar means for reinforcing the retention thread loops developed in closing the incision comprising,

a pair of separate elongate retention bar elements of flexible, pliable, rubbery material resistant to slicing forces and adapted for placement in parallel relation longitudinally extending respectively on opposite sides of the wound incision,

each of said elements being of a companionate length to overlay opposite sides of said incision line in spaced relation thereto,

each bar element being generally of a configuration in cross section having an upper and a lower nonadhesive surface with said lower surface being configured in cross section so that when the element is in normal unstressed condition, a portion of the lower surface contacts the surface of the underlying flesh and the remainder of the lower surface is above the flesh,

the pair of retention bar elements each including a stitch receiving portion extending longitudinally of the bar element for passage therethrough at spaced portions the suture loops along the element and with opposite sides of the loops being opposingly arranged, with loop portions transversely spanning the flesh surface in a network of tie threads, and each of the bar elements including a relatively thick portion to constrain forces drawing the suture loops tautly to be applied generally outwardly of the flesh surface to resist tearing of the flesh and to transfer slicing forces to the element and resist tearing of the flesh,

said elements being deformable in cross section and longitudinally flexible to conform to and yield in response to various stages of swelling as the healing process takes place.

2. The device as set forth in claim 1 wherein said lower surface of each retention bar element is arcuate in transverse extension and defines a fair curve.

3. The device as set forth in claim 2 wherein the portion of the lower surface to contact the flesh surface is continuous along the length of each of the bar elements.

4. The device as set forth in claim 3 wherein the lower portion of each bar element comprises a pair of spaced rib surfaces with each of the rib surfaces having a central zone extending along the lower surface to contact the flesh and with a portion of the lower surface lying between the rib surfaces when said bar element is in a normal unstressed condition.

5. The device as set forth in claim 1 wherein the relatively thick portion of said retention bar is provided with a through recess extending coincident to the length thereof, weakening the cross sectional area of the element and rendering it yieldable to forces of compression.

6. The device as set forth in claim 1 wherein guide line means extending longitudinally of each bar element is provided to designate the stitch receiving portion.

7. The device as set forth in claim 1 including a longitudinally extending plate extending outwardly of the stitch receiving portion and adapted to overlay the zone of contact of the lower portion of the lower surface of each bar element when applied in an unstressed condition in parallel relation of an incision line.

8. The improvement as set forth in claim 7 wherein said plate extends outwardly in flange form of the relatively thick portion of the retention element.

9. The device as set forth in claim 1 wherein the configuration of the retention element defines a figure of eight area in cross section, with the central zone defining said stitch receiving portion and with either of the flanking portions thereof being adapted for use as the relatively thick portion for causing purchase advantage.

10. The device as set forth in claim 1 wherein the exterior surfaces of the retention bar elements are defined in part by a longitudinally extending recess for orientating the stitch receiving portion during use of the elements.