Loop ostomy device and methods for its use

Details Loop ostomy device and methods for its use Loop ostomy device and methods for its use

2002-02-22

2004-04-06

Gibson, Roy D. (Department: 3739)

Surgery

Instruments

C604S327000

Reexamination Certificate

active

06716209

ABSTRACT:

BACKGROUND OF THE INVENTION
1. Field of the Invention
The invention relates generally to abdominal surgery. More particularly, the invention relates to a loop ostomy device used to maintain a portion of the bowel outside of the body and to methods for using such a device.
2. State of the Art
Some abdominal surgery operations require a loop of the bowel to be maintained temporarily or permanently outside the body. These procedures are generally referred to as a “loop ostomy”, “loop colostomy” or a “loop ileostomy” because a loop of bowel is pulled through an incision. In such a procedure, a pouch or similar container is fixed to the skin over the bowel via an adhesive backed wafer. The pouch and wafer which are either made as a one-piece integral unit or as a two piece assembly comprised of a wafer with a flange and a pouch with a flanged open end are commonly referred to as an ostomy appliance.
There are several known apparatuses and kits used when performing a loop ostomy procedure. One such kit is distributed under the trademark GENTLE TOUCH® by ConvaTec, Skillman, N.J. The kits generally include an adhesive-backed wafer having a coupling flange, a drainable pouch adapted to be removably coupled to the coupling flange, and a rod which is used to prevent the loop of bowel from retreating into the body. The kits are available in different sizes based on the diameter of the coupling flange. Prior art
FIGS. 1-5
illustrate a portion of the loop ostomy procedure utilizing the GENTLE TOUCH® kit from ConvaTec.
Referring now to prior art
FIG. 1
, the GENTLE TOUCH® kit includes a loop ostomy device in the form of a rod
10
which is substantially the same as the device described in U.S. Pat. No. 4,671,272. The rigid rod has a fixed cross-piece
12
at one end and a rotatable cross-piece
14
at the other end. Before installing the rod, the rotatable cross-piece
14
is rotated to the position shown in FIG.
1
.
After the abdomen is incised and a loop of bowel is exteriorized, the rod
10
is inserted through the mesentery
15
of the bowel
16
as shown in prior art FIG.
2
. The rotatable cross-piece
14
is then rotated to the position shown in prior art
FIG. 3
so as to prevent the rod from sliding free under the highly slippery surface of the bowel
16
.
With the rod in position, a hole
18
is cut in the wafer
20
as shown in prior art FIG.
4
. The adhesive backing is removed from the wafer
20
; it is positioned over the stoma; and the rod
10
is carefully manipulated so that it lies on top of the wafer
20
within the flange
22
as shown in prior art FIG.
5
. Other (not illustrated) steps in the procedure include incising the bowel
16
and coupling the pouch (not shown) to the flange
22
of the wafer
20
.
The dimensions of the rod
10
and the diameter of the flange
22
are dictated by the diameter of the exteriorized bowel. Thus, several different size kits are typically needed since different patients with different sized exteriorized bowel loops require different sized rods. In many instances, it is deemed prudent to secure the rod with stitches despite the presence of the cross pieces
12
,
14
. Other commercially available rods of alternative designs must be sutured to the skin to prevent dislodgement.
SUMMARY OF THE INVENTION
It is therefore an object of the invention to provide a loop ostomy device.
It is also an object of the invention to provide a loop ostomy device which is usable with an exteriorized bowel of any caliber and various appliance sizes.
It is still another object of the invention to provide a loop ostomy device which is secure without the need for stitches.
It is yet another object of the invention to provide a loop ostomy device which is easy to use, apply and remove and which affords and allows facile replacement of the ostomy appliance while the device is maintained in situ.
It is still another object of the invention to provide a loop ostomy device which is inexpensive to manufacture.
It is yet another object of the invention to provide a method of using a loop ostomy device.
It is also an object of the invention to provide a method of using a loop ostomy device which is usable with an exteriorized bowel of any caliber and various appliance sizes.
It is still another object of the invention to provide a method of using a loop ostomy device which is secure without the need for stitches.
In accord with these objects which will be discussed in detail below, the loop ostomy device of the present invention includes a flexible rod having coupling members at its ends. The diameter length, and stiffness of the rod are pre-selected such that the rod can be inserted through the mesentery of the bowel, folded upward to lie within the pouch and, optionally, form a loop with both ends of the rod coupled to each other via coupling members. A single size rod according to the invention can be used with bowel of any caliber and with a variety of different sized wafers with different diameter flanges. As a result, a hospital need not stock different If sized rods or loop ostomy appliance kits. In addition, the coupling members obviate the need for any stabilizing stitches. The rod is sufficiently rigid to support the bowel but sufficiently flexible to allow it to bend upwardly so as to maintain it within the confines of the flange of the wafer and the attached ostomy pouch (not shown), and optionally, to allow it to loop and couple one end to the other.
According to the presently preferred embodiment, the rod is made of 0.25 inch diameter plastic (PVC) tubing having a 95 Shore A hardness and is approximately 9-12 inches long. The presently preferred device is provided with an hermaphroditic, generally arrow-head shaped injection molded coupling member attached to each end. The entire device may be injection molded as a single unit.
According to the methods of the invention, the surgeon mobilizes and exteriorizes a loop of bowel either through the incision he used to access the abdominal cavity or through a secondary aperture created in the abdominal wall to accommodate the ostomy. Preferably, a Penrose drain (a soft tubular rubber drain) is placed through the bowel mesentery and used to provide gentle traction on the bowel and as a temporary handle to keep the bowel exteriorized. The surgeon then closes the incisions but maintains an opening just large enough to accommodate the exteriorized bowel. An end of the device according to the invention is then maneuvered through the bowel mesentery to replace the Penrose drain.
If a Penrose drain is not used, and the bowel held temporarily outside the body by some other means, then an aperture is created in the bowel mesentery with a clamp, which is then used to grasp the end of the device of the invention and draw the device through the mesentery. The two ends are then folded up and, optionally, interlocked so that the appliance forms a continuous loop around the bowel. The ostomy can then be matured. Maturation of an ostomy involves opening the bowel and circumferentially suturing the opening of the bowel to the skin defect. A wafer with a flange is then prepared and placed around the looped device and the bowel loop and fixed to the skin. The pouch is then attached to the wafer by joining their respective flanges.
The device is sufficiently flexible to form a loop around the bowel. With the coupling members interlocked or not, the device conveniently bends to fit inside an ostomy pouch. This allows the ostomy pouch to form an uninterrupted seal around the ostomy against the patient's skin. Leakage is thereby avoided. However, the device is sufficiently rigid to prevent the bowel loop from retracting into the abdominal cavity.
The shape of the coupling members allows easy passage through the mesentery for placement of the device, but prevents dislodgement. Interlocking the two coupling members makes dislodgement even more unlikely.
The device is provided to the surgeon as one unit, and does not require assembly. No suturing is required to secure the device to the skin or subcutaneous tissue. The device i

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