Triple cushion sphincteric web

A sphincteric web for the treatment of incontinence having a particular alignment of three inflatable pressure cushions by which to prosthetically replicate the geometry of a normally continent rectum. The sphincteric web surrounds and embraces a patient's colon (or rectum), and the pressure cushions are inflated with hydraulic fluid from a hypodermically accessible source thereof. The inflated pressure cushions produce axial, deflective forces which closely mimic the three valvular deflections produced by the rectal valves in a healthy anatomy. Accordingly, the patient's colon is deflected, rather than constricted or obstructed, to increase the resistance to the flow of waste material and thereby return the patient to continence.

BACKGROUND OF THE INVENTION 
1. Field of the Invention 
This invention relates to a sphincteric web for the treatment of 
incontinence having three inflatable cushions by which to prosthetically 
replicate the geometry of a normally continent rectum and, thereby, return 
the patient to continence. 
2. Prior Art 
In a colostomy or ileostomy patient, some or all of the large intestine may 
have been removed due to cancer, inflamatory bowel disease, and other 
infectious causes requiring excision and resection. Surgically implantable 
prosthetic sphincters are known by which to treat colostomy or ileostomy 
patients for incontinence. However, conventional artificial sphincters 
commonly include an occlusion cuff which surrounds and squeezes the colon 
to achieve continence through the application of equal and opposite forces 
in a single plane. Such coplanar force-generating sphincters act to 
constrict the colon so as to create an obstruction for blocking the flow 
of waste material therethrough. 
However, by constricting or squeezing the colon to achieve continence, 
blood flow through the patient's delicate tissues may be undesirably 
interrupted or impeded. Consequently, there exists a likelihood that the 
patient will be susceptible to hypertrophy, ischemia, necrosis and/or 
erosion, thereby requiring further surgery and the removal or adjustment 
of the sphincter. 
Examples of conventional artificial sphincters which include a plurality of 
inflatable chambers by which to treat incontinence may be found by 
referring to either of U.S. Pat. Nos. 4,399,809 issued Aug. 23, 1983 or 
4,428,365 issued Jan. 31, 1984. 
SUMMARY OF THE INVENTION 
Briefly, a sphincteric web is disclosed for the treatment of incontinence. 
The sphincteric web is particularly adapted to surround and embrace the 
colon (or rectum) of a colostomy or ileostomy patient where some or all of 
the large intestine has been removed due to cancer or infectious disease 
and/or the natural sphincter muscles are rendered functionally inoperative 
due to age, trauma, or sphincteric dysfunction. The sphincteric web has 
three inflatable pressure cushions which are aligned with one another so 
as to prosthetically replicate the geometry of a normally continent 
rectum. That is to say, with the sphincteric web surrounding the colon, 
the pressure cushions are inflated with hydraulic fluid to produce axial, 
deflective forces which closely mimic the valvular deflections produced by 
the rectal valves of a healthy anatomy. 
When the pressure cushions are inflated, the deflective forces applied to 
the colon are directed in respective planes that are aligned transvesely 
to the orientation of the colon. More particularly, the pressure cushions 
are spaced longitudinally from one another, such that no two of the 
deflective forces produced thereby are applied to the colon in the same 
plane. Such non-coplanar forces establish a deflection of the colon to 
restrict the movement of material therethrough. 
A pair of pressure cushions are positioned at opposite sides of the 
sphincteric web in alignment with each other and the longitudinal axis of 
the web. The third of the pressure cushions is positioned at one end of 
the web and in alignment with the lateral axis thereof. The sphincteric 
web is implanted in a perianal location with a plane created by the center 
line of the pressure cushions oriented in anterior-posterior midline 
alignment. A pair of buttons is formed at one end and a pair of 
buttonholes is formed at the opposite end of the sphincteric web. The 
sphincteric web is folded around the patient's colon and the opposite ends 
of the web are connected together by inserting the buttons through the 
buttonholes. 
By virtue of the present sphincteric web, the patient's colon is deflected, 
rather than constricted or obstructed, to increase the resistance to 
material flow and thereby return the patient to continence. Moreover, such 
deflection is accomplished by means of the non-planar geometry of the 
pressure cushions so as to avoid the possibility of strangulating the 
colon, whereby to reduce the likelihood of hypertrophy, ischemia, necrosis 
and/or erosion.

DESCRIPTION OF THE PREFERRED EMBODIMENT 
Referring now to the drawings, there is shown in FIG. 1 a sphincteric web 1 
which forms the prosthetic sphincter of the present invention. Sphincteric 
web 1 comprises a plurality of (e.g. three) inflatable, hemispheric 
pressure cushions 2, 3 and 4. As will be explained in greater detail 
hereinafter, the pressure cushions 2, 3 and 4 are controllably inflated to 
prosthetically deflect the colon of an incontinent colostomy or ileostomy 
patient, whereby to return a patient to continence by mimicing the natural 
deflective forces which would normally be provided by the patient's rectal 
valves. Pressure cushions 3 and 4 are positioned at opposite sides of web 
1 (along the longitudinal axis thereof). Pressure cushion 2 is positioned 
at one end of the web (along the lateral axis thereof). In this manner and 
as will be understood when referring to FIG. 9, the sphincter web 1 will 
be able to artificially replicate the geometry of a normally continent 
rectum when the web is attached around the patient's colon. 
As will be known to those skilled in the art, the rectal valves may be 
rendered functionally inoperative or may require excision (along with the 
patient's rectum) as a consequence of cancer, inflamatory bowel disease, 
trauma, age, or other sphincteric dysfunction. Inamuch as there are three 
rectal valves in the human anatomy (i.e., the superior, medial, and 
inferior rectal valves), sphincteric web 1 is preferably provided with 
three pressure cushions 2, 3 and 4. However, the precise number of 
pressure cushions utilized could be varied according to the tissue 
requirements of a particular patient. 
The inflatable pressure cushions 2, 3 and 4 are maintained in a desired 
alignment with one another by a flexible, minimally extensible positioning 
and tensile resistant webbing 6 to which the pressure cushions are 
attached. Webbing 6 is preferably fabricated from a polyester based, 
bicompatible, silicon reinforced mesh. One or more slots 8 may be formed 
in the webbing 6 to increase the flexibility thereof. Webbing 6 has a pair 
of buttonholes 10 formed through a primary fastening end 11 thereof. An 
optional closure tab 12, also having a pair of buttonholes 14 formed 
therethrough, is coextensively formed with an extended outwardly from a 
secondary fastening end 13 of webbing 6 at a location adjacent one of the 
pressure cushions 2. A pair of buttons (designated 22 in FIGS. 2 and 3) is 
formed at the top of pressure cushion 2. The purpose of buttonholes 10 and 
14 and buttons 22 will be described when referring to FIGS. 2 and 3. 
The periphery of webbing 6 surrounds adjacent primary and secondary 
openings 15-1 and 15-2. The openings are separated from one another by a 
longitudinally extending linking member 16. Linking member 16 also 
mechanically connects and supports a pair of pressure cushions 3 and 4. 
The presence of primary and secondary openings 15-1 and 15-2 maximizes the 
flexibility of and permits sphincteric web 1 to be folded around a 
patient's colon in a manner which will soon be disclosed. 
A fluid circuit for controllably inflating (or deflating) the pressure 
cushions 2, 3 and 4 of sphincteric web 1 is now disclosed while continuing 
to refer to FIG. 1. Fluid is transferred into and out of the pressure 
cushions 2, 3 and 4 by way of flexible, non-kinking hydraulic tubing 17. 
Hydraulic tubing 17 extends between a source of hydraulic fluid (e.g. a 
radio opaque, physiological saline solution, or the like) and one of the 
inflatable pressure cushions 4. One example of a suitable fluid source is 
a hypodermically accessible fluid infusion port or reservoir, such as that 
described in U.S. Pat. No. 4,634,443 issued June 18, 1986. A pair of 
series connected fluid lines 18 and 20 extend through webbing 6 between 
pressure cushion 4 and respective pressure cushions 2 and 3. Accordingly, 
a fluid path is established from the fluid source to each of the 
inflatable pressure cushions 2, 3 and 4 via tubing 17 and fluid lines 18 
and 20. 
The method by which the sphincteric web 1 embraces a patient's colon (shown 
in phantom and designated by reference numeral 50) so that the geometry of 
a normally continent rectum can be artificially replicated is now 
described while referring to FIGS. 2 and 3 of the drawings. In FIG. 2, the 
sphincteric web 1 is folded around the colon 50, such that the buttonholes 
10 in primary fastening end 11 and the buttonholes in the secondary 
fastening end 13 lie adjacent one another below the patient's colon 50. As 
is best shown in FIG. 2, a pair of buttons 22 projects upwardly from the 
top of pressure cushion 2. 
To interconnect the primary and secondary fastening ends 11 and 13 of the 
sphincteric web 1 so that the web will completely surround the patient's 
colon 50, the closure tab 12 at the secondary fastening end 13 is pulled 
through the primary opening 15-1 in the primary fastening end 11 in a 
direction indicated by the reference arrow 24. Closure tab 12 is 
positioned behind the primary fastening end 11, such that the buttonholes 
in tab 12 and primary fastening end 11 are aligned with one another. 
As is best shown in FIG. 3, the primary fastening end 11 is rotated into 
engagement with the pressure cushion 2, and the buttons 22 of cushion 2 
are moved through the buttonholes 10 in primary fastening end 11, whereby 
to attach primary fastening end 11 to secondary fastening end 13. Next, 
the closure tab 12 is rotated over primary fastening end 11, and the 
buttons 22 of pressure cushion 2 (which extend through the button holes 10 
in primary fastening end 11) are also moved through the buttonholes 14 in 
tab 12, whereby to secure the closure tab 12 over the primary fastening 
end 11. 
By virtue of the buttons 22 and the buttonholes 10 and 14, interlocking 
means are provided by which the primary and secondary fastening ends 11 
and 13 of sphincteric web 1 may be reliably connected together. The 
optional closure tab 12 provides a redundant locking feature which, with 
the cooperation of primary fastening end 11, ensures that the primary and 
secondary fastening ends 11 and 13 of sphincteric web 1 will not be 
accidentally detached from one another after the implant surgery has been 
completed. However, in some cases, it may be desirable to eliminate 
locking tab 12, altogether, whereby the primary and secondary fastening 
ends 11 and 13 of sphincteric web 1 are connected together solely by means 
of buttons 22 and buttonholes 10. 
FIGS. 4 and 5 of the drawings show the sphincteric web 1 surrounding and 
embracing the patient's colon 50. It is to be understood that the 
horizontal alignment of web 1 and colon 50 in FIGS. 4 and 5 is for 
purposes of illustration only. In actuality, the sphincteric web 1 and 
colon 50 generally extend in vertical alignment with one another through 
the patient's body (in the manner depicted in FIG. 9). 
The operation of sphincteric web 1 is now decribed while referring to FIGS. 
6, 7 and 8 of the drawings. FIG. 6 shows the web 1 at rest with the 
inflatable pressure cushions 2, 3 and 4 deflated. However, the fluid 
circuit including pressure cushions 2, 3 and 4 and hydraulic tubing 17 may 
be initially filled with minimal fluid to equalize the internal and 
atmospheric pressures. Accordingly, the patient's colon 50 is relaxed 
(i.e., neither deflected nor restricted) so that waste material may pass 
freely therethrough. 
In FIG. 7, hydraulic fluid is applied from the source thereof via tubing 
17, to a first of the pressure cushions 4 of sphincteric web 1. As 
previously disclosed when referring to FIG. 1, pressure cushion 4 
communicates with pressure cushions 2 and 3 by way of a pair of series 
connected fluid lines (designated 18 and 20 in FIG. 1). Therefore, fluid 
is transferred from cushion 4 to cushions 2 and 3, whereupon each of the 
pressure cushions 2-4 begins to inflate. In FIG. 8, the pressure cushions 
2-4 of sphincteric web 1 are fully inflated. In the fully inflated 
condition, each cushion assumes a hemispheric configuration by which to 
apply successive deflective forces to the patient's colon 50 for the 
purpose of deflecting the colon and restricting the movement of material 
therethrough. Of course, the pressure cushions 2, 3 and 4 may be deflated 
by withdrawing fluid from the cushions to the source by way of tubing 17, 
whereby to return colon 50 to the non-deflected, non-restricted condition. 
Referring now to FIG. 9 of the drawings, the sphincteric web 1 is shown 
surrounding and embracing the rectum 26 of a healthy, normally continent 
patient. FIG. 9 is provided to show the disposition and relationship of 
web 1 to the healthy anatomy. That is to say, the pressure cushions 2-4 of 
web 1 are particularly positioned to artificially replicate the geometry 
of a normally continent rectum so as to return an incontinent patient to 
continence by closely mimicing the three valvular deflections produced by 
the patient's rectal valves 28-1, 28-2 and 28-3. 
Thus, when the pressure cushions 2-4 are inflated, the deflective forces 
produced thereby are directed in respective planes which are aligned 
transversely to the orientation of the colon. The pressure cushions 2-4 
are spaced longitudinally from one another, such that no two of the 
deflective forces are applied to the colon in the same plane. Such 
non-coplanar forces establish the deflection of the colon to restrict the 
movement of material therethrough. 
In the case of a colostomy or ileostomy patient, both the rectum 26 and the 
continence producing rectal valves 28-1, 28-2 and 28-3 thereof are 
typically excised. Therefore, sphincteric web 1 preferably surrounds and 
embraces the patient's colon 50 as a means for enabling the patient to 
overcome incontinence. In other cases where, due to sphincteric 
dysfunction, urological damage, trauma, age, catastrophic injury, or the 
like, either the natural sphincter muscles 30 of the patient are removed 
and/or the rectal valves are rendered functionally inoperative, the 
sphincteric web 1 preferably surrounds and embraces the patient's rectum 
26 (as shown) to augment or assist any remaining natural sphincteric 
and/or valvular function to achieve patient continence. 
Thus, regardless of whether the sphincteric web 1 surrounds the patient's 
rectum 26 or colon 50, inflating the pressure cushions 2, 3 and 4 
artificially and prosthetically produces axial deflective forces which 
closely replicate the natural valvular deflections produced by the rectal 
valves 28-1, 28-2 and 28-3 in a healthy anatomy. The deflective forces 
produced by sphincteric web 1 cause increased resistance to the flow of 
material through the rectal or colon, whereby to return the patient to 
continence. 
By virtue of the present sphincteric web 1, a colostomy or ileostomy 
patient may be prosthetically returned to continence through the 
application of axially deflective forces rather than potentially damaging 
obstructive forces. More particularly, the deflecting or bending of the 
patient's colon (or rectum) as caused by inflating pressure cushions 2-4 
restricts material flow according to a non-planar geometry instead of 
constricting material flow according to a planar geometry, as is 
undesirably characteristic of conventional occlusive force-generating 
sphincteric devices. In other words, instead of achieving continence by 
squeezing the colon to create an obstruction, sphincteric web 1 returns 
the patient to continence by deflecting the colon while avoiding the 
possibility of strangulation. Therefore, a patient receiving sphincter web 
1 is less likely to be susceptible to hypertrophy, ischemia, necrosis 
and/or erosion because of the non-planar deflective manner in which 
continence is achieved. 
It will be apparent that while a preferred embodiment has been shown and 
described, various modifications and changes may be made without departing 
from the true spirit and scope of the invention.