Rectovaginal surgical repair instrument

A rectovaginal surgical instrument for the repair of rectovaginal tears, incisions and fistulas, especially those associated with childbirth. The instrument includes an elongated generally cylindrically shaped member, one end being continuously curved toward a tip and the other end having a flange and optionally wing guides, curved, or post guides, for retaining and/or guiding forceps or other surgical instruments.

FIELD OF INVENTION 
The present invention relates to a surgical device to aid in the repair of 
rectovaginal tears, incisions and fistulas, especially those which occur 
in connection with childbirth and require suturing at the conclusion of 
the childbirth process. 
BACKGROUND OF THE INVENTION 
Despite the many advances in modern medical and surgical procedures, there 
are some procedures which remain relatively unchanged. 
In childbirth, tissue in and around the vagina and the vaginal opening 
quite often is torn or is surgically incised in an episiotomy during or in 
anticipation of parturition. Such tears or incisions must be surgically 
repaired by suturing after delivery. During the period before the repair 
has been accomplished, the mother may be in considerable discomfort and 
may be bleeding heavily. There is a need to accomplish the suturing as 
quickly as possible to relieve or minimize the discomfort and decrease the 
amount of blood loss. 
The difficulty in making surgical repairs of episiotomies or third or 
fourth degree lacerations in the rectovaginal area is that suturing must 
be done on muscle and other tissue in a body area where there is 
restricted access and often bleeding and other body fluids. As a 
consequence, physicians and other healthcare attendants involved in such 
repair procedures most frequently insert one of their own fingers into the 
patient's rectum to maintain separation of the upper and lower portions of 
the rectum, and to provide appropriate firmness. 
The use of the human finger in such manner has many disadvantages. One 
important problem is that the physician or healthcare attendant must sew 
with only one free hand available for that purpose, the other hand being 
used to provide the support for the tissue being sutured. Second, the 
process is slow in that the suturing must be constantly checked to insure 
that it is not too deep, that there are no gaps, and that the suturing is 
otherwise proceeding properly, all of which prolongs the discomfort of the 
patient and potentially increases blood loss. There is also an increased 
risk of infection to both the healthcare provider and the patient. If the 
nurse is asked to place a finger in the rectum, the procedure goes 
somewhat faster, but the risk of infection remains in the event of the 
needle pricking the finger. 
There is no surgical instrument available to physicians or healthcare 
attendants to provide these functions in connection with such suturing. On 
occasion, it is said that test tubes have been used, but clearly this is 
not a proper use for test tubes, which can break, causing severe cuts, and 
which can potentially slide wholly inside the rectum, necessitating 
retrieval. 
A search of medical literature, patents and surgical instrument catalogs 
does not reveal any instrument available to provide support to aid in the 
suturing in the context considered here. Clearly, there is a need for an 
instrument which provides the necessary support, not only in the case of 
vaginal tear s and episiotomies, but also in the case of colostomies and 
other operations in the vicinity of the vagina and anus. The Peters U.S. 
Pat. No. No. 4,964,417, dated Oct. 23, 1990, reveals a wound closure aid 
designed to cover, protect and retain internal organs in the course of a 
wound repair, by being tucked under adjacent tissue and then withdrawn 
just before the wound is completely closed. It is designed for a different 
purpose and, being of a generally two-dimensional curved configuration, 
would not at all be suitable for suturing an episiotomy. In addition, 
British patent 638,892, published Jun. 14, 1950, reveals a device for 
insertion of sutures prior to delivery in the area where the incision is 
expected to be made, so that the incision can be closed after delivery 
imply by "lacing up" the sutures which have been pre-inserted. The British 
patent does not appear to have been significantly utilized, if at all, 
possibly because of dangers to the child --and possibly to the mother 
--arising from delivery across in-place sutures which could pose both an 
impediment to delivery and possible dangers. In any case, the instrument 
would be useless as an aid to suturing after an episiotomy not involving 
previously inserted sutures. There are rectal dilators designed to deal 
with bowel prolapse and to inject medication into the rectum, such as Lott 
U.S. Pat. No. 988,120, issued Mar. 28, 1911 and British patent 233,903 
issued May 21, 1925. There are also vaginal dilators such as is 
exemplified by the Waters U.S. Pat. No. 2,763,265 issued Sep. 18, 1956. 
However, the irregular shape of these instruments and the holes in one of 
them render these instruments unsuitable as aids in suturing. Nor has 
anyone, to the inventor's knowledge, ever suggested that they be employed 
as an aid for suturing. 
The present invention in one preferred embodiment is a smooth rigid 
cylinder, sized to fit snugly, with a continuous curved tip at one 
extremity thereof and with a rim-type flange devise at the opposing 
extremity thereof which also optimally allows some manipulation, if 
useful, of the inserted cylindrical portion of the invention. To enhance 
the usefulness of the inventions, rigid "wing" devices may be incorporated 
on or near and rigidly attached to the flange or stop which can help, when 
engaged with forceps which are used to hold the sphincter in place for 
later suturing and to retain the invention in its proper place during 
suturing, thus freeing the hands of physicians and healthcare attendants 
to do their work with a minimum of obstructions. Although this invention 
is relatively simple and uncomplicated, it serves a function and satisfies 
a need for which there is no other surgical instrument. The need is clear, 
and it is significant that the thousands of obstetricians, gynecologists, 
physicians, and midwives throughout the world who regularly deliver babies 
have thus far not, to the applicant's knowledge, produced or used such a 
devise, nor have the medical supply industries which are constantly 
seeking new and improved surgical products.

DETAILED DESCRIPTION OF THE DRAWINGS 
Referring to FIG. 1, an elongated cylindrical member 1 has a rounded or 
blunted end 2, which is the end designed for insertion into the patient. 
"Wing" devices 3 are affixed at the opposite end therefrom in which to 
engage the handles of forceps in a manner to be described below. Wings 
serve also to immobilize substantially the instrument after insertion, to 
prevent migration further into or regression from the patient, when the 
forceps at one end are engaged with the wings and at the other end are 
grasping muscle tissue, as detailed below. While the wing devices 3 
preferably curved inwardly but without touching, the wing devices 3 could 
be like a pair of posts not curving inwardly, in which case they would 
function as guides and stops for the forceps but would not actually engage 
the forceps to the extent of inwardly curving wings. (See discussion in 
connection with FIG. 5 below.) On the other hand, the wing devices could 
curve inwardly and meet, or even form a continuous loop, encircling the 
forceps inserted therein. 
FIG. 2 is a view of the invention shown in FIG. 1, shown from the wings-end 
thereof and looking along the axis of the elongated cylindrical member. An 
end of the elongated cylindrical member 1 is shown, as well as the wing 
devices 3. In addition, in this embodiment there is shown a flange 4 which 
serves as an enhancement of the "stop" function of the wing devices 3. It 
should be noted that the flange 4 appears on only one side of the wing 
devices 3. The reason for limiting the flange 4 to one side only is that a 
flange extending all the way around would interfere with the suturing and 
medical care being administered by the healthcare professional, as will be 
explained later in this specification. 
FIG. 3 shows a pair of forceps 5 engaged with the wing devices 3. In an 
episiotomy repair procedure, the extremities 6 of the forceps 5 would be 
grasping sphincter muscle tissue having previously been severed, to hold 
such tissue together for suturing after parturition. By engaging the 
forceps 5 with the wing devices 3, the forceps 5 perform the dual function 
of retaining in place the member 1 of the invention and at the same time 
positioning the sphincter muscles for suturing. 
FIG. 4 shows an elongated cylindrical member 1 with rounded or blunted 
extremity 2 and a partial flange 4 attached to the end opposite said 
extremity. Extremity 2 is inserted into the patient, and flange 4 serves 
both as a stop and as a means for facilitating retraction of the 
instrument from the patient. To avoid obstructing or impeding the suturing 
procedures, the flange should not normally extend substantially farther 
than 180.degree. about the circumference of the elongated cylindrical 
member. For certain limited situations, it is possible that a flange 
extending farther would not be disadvantageous; but for general use it 
would be desirable that there be no flange across a significant part of 
the circumference so that the flanged portion can be positioned in a 
direction to avoid obstruction of work while serving as an effective stop. 
It is to be noted that FIG. 4 shows the invention without the wing devices 
which are a part of the invention as shown and discussed in connection 
with FIGS. 1-3. Some physicians and healthcare professionals may prefer to 
work with the invention without wing devices because of a preference for 
having forceps free of any restraint on their mobility, and the embodiment 
of FIG. 4 is designed for use in that event. 
FIG. 5 shows an alternative embodiment of the invention, similar to FIG. 
1-3, except that the wing devices 3 in FIG. 5 are posts which serve 
primarily as lateral guides. This configuration allows for relatively 
greater maneuverability than the inwardly curving wings and may be 
considered desirable where one wishes to have forceps engaged sufficiently 
to retain the invention in place but simultaneously free enough to 
"escape" instantaneously without the concern of disengaging from the 
inwardly curving wing devices shown in FIGS. 1-3 above. Obviously, there 
could be a row of post wings on opposing sides or there could be post 
wings of a rectangular "wall" configuration, and nothing herein is 
intended to limit the invention to any particular configuration. 
FIG. 6 shows the flanged end of still another an alternative preferred 
embodiment of the invention. The opposing end not shown is substantially 
the same as the corresponding parts of the invention as shown in FIGS. 1, 
3, 4 and 5 above. However, clip or fastener means 6 have been provided to 
secure forceps (not shown) with even greater security than that 
represented by the wing devices of FIGS. 1-3, and 5, above. This 
configuration of the invention would be used when the highest degree of 
security and stability is desired, as opposed to the loose and slightly 
more maneuverable configuration represented by the wing devices of FIGS. 
1-3. The clip or fastener means 6 can be of any design which will secure 
and hold the forceps tightly, such as a hasp or pinch-type clip or any 
other clip or fastener design. 
The subject invention can be made of any smooth, rigid, non-toxic material, 
but the material should preferably be nonmagnetic, to avoid attraction to 
surgical instruments during suturing procedures, and nonbreakable under 
normal noncompressive use. The subject invention should also preferably be 
impervious so that germs, bacteria and viruses do not become imbedded in 
the pores, especially if the instrument might possibly be reused. 
Normally, the instrument can be reused if it can be effectively and 
efficiently sterilized after use, which generally will require that it be 
impervious and able to withstand heat and/or chemical and/or ultrasound or 
other sterilization substances and procedures. Non-magnetic surgical 
stainless steel or a tough acrylic or plastic will be suitable. The 
instrument can optionally be hollow or solid. It will often be useful if 
the instrument weighs at least several ounces, since a greater mass tends 
to prevent its being dislodged or ejected after insertion as a result of 
natural muscle contractions in the rectum. 
The diameter of the elongated member 1, as shown in each of the respective 
drawings, at its widest point should normally be in the range of 1 cm to 4 
cm, generally approximately 2 cm. It would normally be unnecessary for 
said elongated member 1 to exceed 15 cm in length and it will normally 
need to be longer than 3 cm to be effective, with an optimal length being 
approximately 8 to 10 cm. The partial flange 4 in aforesaid drawings 
normally should extent out at least 0.5 cm from the circumference of 
elongated member 1. The wing devices 3 should not need to exceed 8 cm from 
outer tip to outer tip nor should they normally be shorter from outer tip 
to outer tip than the diameter of said elongated member 1 at its widest 
point. The wing devices may touch each other as they curve inwardly, or 
even form a continuous loop, although the disengagement of the forceps 
from the wing devices is facilitated when there is some open space between 
the two wing devices.