Note: Descriptions are shown in the official language in which they were submitted.
n n
~- 1 3290~80
65895~147
Thls lnvention relates to rectal insertlon tubes; and
,
more particularly relates to a novel and improved speculum and
. control valve ln regulating the dellvery to and removal of
,~ liquids from the rectum.
. ~,r,
~'t,' A Canadian patent appllcatlon entitled "BOWEL CARE
APPARATUS", Serlal No. 610,408, flled 6 September, 1989, and
asslgned to the asslgnee of the present inventlon 15 flled
~ `f
S
~ concurrently herewlth.
.~f~ ~ The rectum 15 a very dellcate part of the human body
`f~ 10 and, as such, requlres that lt be protected from abraslon,
per~oration, infectlon as well as excesslve pressure. Accord-
~,; ln~ly, any devlce w~llch is intended for rectal insertlon should
~,~ not have any tendency to perforate the rectal wall even ln com-
~
lng into contact wlth the wall during lnsertlon, must not have
:,,.
sharp contactlng edges, and must ojpen the anal sphlncter as
evenly as posslble wlth the support o~ maxlmum circumference of
t~ ~
dllatlon and at a rate whlch ls initlally hlgh ~nd gradually
reduces to a low rate as dllutlon reaches a maxlmum. In the
~. ,
use of a speculum which ls intended for the dellvery of liquld
:, 20 lnto the rectum, it ls lmportant that water or llquld flow not
be concentrated at any spot on the mucosa of the anal canal and
f' which would tend to constantly traumatize an area ln the lmme-
s dlate vlclnlty of the operating position. Further, the specu~
~ lum should offer the maxlmum posslble aperture for free flow to
`~ mlnlmlze back pressure durlng moments of peristalsis. It is
:~ also desirable tha$ the speculum be blased so a~ to be drawn
,;',~fj~ lnto the rectum under anal contractlon and lnclude an anal rlng
;.
~ or stop to regulate penetratlon depth as well as prevent lPak-
. ...
~J'' age durlng use.
~ ~f~
. ,~ .
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` 1 329080
.,
Various different types and designs of rectal
tubes have been devised in the past. For example, U.S.
Letters Patent No. 1,198,742 to C. W~ Meinecke discloses a
double-ended tubular retainer system to which a discharge
; tip and inlet may be added. However, the portion which is
intended for insertion into the anal canal is a straight
,,
parallel tube with offset apertures or openings through
which a saline solution is to be discharged. U.S. Letters
Patent ~o. 1,853,202 to D. B. Catlin similarly employs a
relatively straight tube with a gradual forward taper at
the leading end. The device is made of a rigid sterili-
zable material and includes a three-way valve which is
manually controlled to determine direction of flow. In
U.S. Letters Patent ~o. 1,710,701 to H. Hertsberg, an
insert tube has a leading, gradually tapered forward tip
~ which forms a solid end of a generally tubular body, the
$
; body also being gradually tapered in a forward direction
';:
;~ and having forwardly tapered, diametrically opposed aper-
~ tures or openings which are large enough to permit the
;$~ 20 passage of liquid as well as solid waste matter. In addi-
tion, a shoulder is formed at the trailing end of the tube
, ~,
to limit the depth of penetration into the anal canal. For
irrigating purposes, a flexible hose extends from an ele-
vated water bag into the trailing end of the speculum for
delivery of water under presuxe into the rectum and a drain
line is manually closed off by doubling it upon itself
during the injection of water. Tn order to discharqe the
water from the colon, a larger opening or drain line is
opened so as to permit the removal of water and any fecal
:j
matter dislodged from the intestinal tract. Nevertheless,
-- 2 --
~ 3290~0
65895-147
the above and other slmllar types of rectum lnsertlon devlces
fall to ellmlnate the posslbility of occludlng the aperture of
the speculum eye thereby causlng undue pulllng on the mucosa
.,.
during the draln interval so as to insure the most complete and
total ellmination as possible as would normally occur durlng a
bowel movement. Other lmportant conslderations have to do with
the proper dllation of the anal canal durlng insertlon of the
speculum followed by anal contraction to effectlvely lock the
. speculum ln place, proper orlentation wlth respect to the rec-
,; 10 tum, and at the same time llmi~ing lts depth o~ penetration.
In copendlng Canadlan patent appllcatlon, Serlal No.
610,408 for "~OWEL CAR~ APPAR~TUS", there ls set forth and
descrlbe~ a novel and lmproved system for colonic lavage in
. which a pump circuit ls provlded to dellver water from a flll
.~ receptacle under pressure through a flll llne and speculum into
~!~ the colon, there belng a drain line extendln~ away from the
:~ speculum and a valve ln the drain :Llne whlch ls movable to a
:~. closed posltion when water pre~sure in the pump exceeds the
,~ water pressure in the speculum and to an open positlon when the
,~ 20 water pressure ln the speculum e~ceeds that ln the pump.
~ eature of the present lnvention is to provide for a new and
; lmproved speculum to overcome the drawback of prior art de-
vices; and also to provlde for a novel and lmproved valve which
~ is specifically lntended for use ln lavage apparatus as des-
-` cribed and whlch ls sensitlve to differential pressure of the
-.~ liquld between the pump and patient to cooperate ln regulating
filllng and drainlng of the liquld to and from the patient.
; .
,
"
X 3
.
1 32qO80
`:
Accordingly, it is an object of the present inven-
tion to provide for a novel and improved rectal insertion
tube and specifically to provide for a speculum which can
be placed in the anal canal and lower rectum for the intro-
- duction of water or other liquid into the rectum, sigmoid
colon and the remainder of the large intestine if desired;
and further wherein the same speculum may be employed fox
draining liquids and fecal matter out of the colon.
It is a further object of the present invention to
~ 10 provide for a novel and improved speculum and control valve
~ which are conformable for use in various colonic lavage
.^; apparatus to carry out either pressure-controlled or timer~
. controlled fill and drain cycles in an effective and dep~n-
~ dable manner.
$ ~et another objective of the present invention is
~ to provide for a novel and improved speculum which will
:~i effectively minimize the abxasion, perforation or infection
i~ o~ the anal canal and rectum when employed in bowel care
r.~, .
' treatment devices.
' 20 It i~ an additional object of the present inven-
~ tion to provide for a speculum which when inserted into the
`~ anal canal of a patient will encourage proper dilation and
anal contraction while limiting the depth of penetration
:,.~, .
when inserted; and in the course of insertion and removal
into and from the anal canal will minimize any danger of
damage resulting from abrasion, perforation of mucosa or
.
~ pulling down of hemorhoids but will insure most complete
, .
~. and total elimination possible of the bowels when employed
'J in colonic lavage operations.
An additional object of the present invention is
to provide for a novel and improved control valve which
~,,
_ ~ _
. .
~,
1 :32~080
, 658g5-147
will au~omatically regulate filllng and draining o~ the aolon
in response to the preSSurQ differential of a liquld delivered
from a liquid supply pump.
In accordance with the present inven~lon~ there is
.
provided in colonic lavags apparatus including a gpeculu~ for
insertion into the anal canal of a patient for the
.
bldirectional flow of fluid therethrough, sald speculum
comprisiny, an elongated tubular body havlng a hollow interior
and t~rminatlng at one end in a ~apered leading end and at an
opposite end in a tubular ~railing end, said body havlng a
maximum dlam2ter ad~acent to but rearwardly o~ ~ald tapered
leading end and a portion tapering rearwardly from said maximum
dlame~er area, said tapered leading end being provided with at
least one aperture communicating with the interior of said
...~
body, each said aperture having a rear~ard portion diverying
forwardly for the greater length of each said aperture and
~ having rounded edges surrounding ~a:Ld aparture; and an anal
:~: stop adjacent said traillng end of æaid body, 3aid maximum
~^~ diameter area located relatlvely near sald leading end and away
~f'.' 20 fro~ said ~nal stop.
.: Eor use in conjunction therewith as a part of a
;~; di~posable colonic lavage apparatus is a control valve in close
s`.: proximity to tha speculum and having an outer relatively
inflexible tubular conduit wlth one çnd connected to the
speculum and an opposite end connected to an end of the drain
line. An elastic tubular liner i8 inserted within and
coextensive with the tubular conduit, the flexible liner being
of a diameter correspontling to that of ~he lnner diameter of
the condui~ and connected at oppo~ite ends to the opposite ends
~ 33 of the conduit, and a control port in a wall of the conduit is
.: ln com~unication wlth an annular space surrounding ~ha liner
i` and communicate~ wl~h means for supplying fluid under pressure
. ~ .
. , ~ 5
,
.,
~ 3~9~80
65~95-147
whereby to open and close the liner in re~ponse to the
differentlal pressure between the pre~sure in the control port
and the interior o~ the valve body. In thiæ way, when liquid
under pressure is supplied through the ~peculum and
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1 3290~0
is also in communication with the control port for the
vaive, the valve will be closed as long as liquid is being
delivered under pressure through the speculum into the
~r~,; colon of a patient. However, when delivery of liquid is
in~errupted and the pressure is reduced at the control port
;.:
into the valve, the hydrostatic head of liquid from the
,~ patient will be sufficient to open the valve to permit
;` draining from the colon area through the drain line.
~" Other objects, advantages and features of the pre-
'.~ 10 sent invention will become more readily appreciated and
: ~i
understood when taken together with the following detailed
description in conjunction with the accompanying drawings,
:i:
~ in which: .
:::
~; Figure 1 is a longitudinal section view o~ a pre-
ferred form of speculum and valve unit in accordance with
~. ...
'r~ the present invention;
Figure 2 is a cross-sectional view taXen about
lines 2-2 of Figure l;
.. Figure 3 is a cross-sectional view taken about
:?:
:~ 20 lines 3-3 of Figure l;
.. Figure 4 is a cross-sectional view taken about
: lines 4-4 of Figure l;
r Figure 5 is a cross-sectional view taken about
`: lines 5-5 of Figure l; and
Figure 6 is a longitudinal section view of the
~` preferred form of ~peculum taken at right angles to the
;::
section view of Figure 1.
............ Referring in more detail to the drawings, a pre-
~, ferred form of assembly 10 i8 broadly comprised of a specu-
30 lum 12, T-shaped fitting 14, a liner valve 16, and a
:~. coupling 18. The elements 12, 14, 16 and 18 are assembled
!. 6
~ ,:
1 ~9080
- together in fixed, end-to-end, coaxial relation to one
another and are of progressively increasing diameter from a
forward or leading end 20 of the speculu~ through the valve
~; coupling end portion 18 so as to present an unobstructed
passage for flow of liquid and solid materials
therethrough. As a setting for the present invention, the
speculum and valve assembly will be described as forming a
part of a colonic lavage apparatus in which a liquid fill
or delivery line represented at L is affixed to inlet port
or fitting 22 which forms the stem of the T-shaped fitting
14 and a pressure control line L' is connectable to
pressure port or fitting 24 on the control valve 16; and
further, a drain line D is connectable to coupling end por-
tion 18. In this setting, the speculum is intended for
insertion into the anal canal of a patient and water is
delivered under pressure from a pump P or other source of
water under pressure via inlet port 22 through the speculum
into the rectum or colon area of a patientO The fluid
delivered via line L' and pressure port 24 is at the
pressure level of the same pump P that delivers water under
pressure to the port 22. However, by virtue of the -free
flow of water through the speculum into the colon area, as
opposed to the flow of fluid through pressure port 24 into
a confined annular space 26 in surrounding relation to a
~lexible or elastomeric liner 28, the differential pressure
is such that it will cause the liner to be constricted into
a closed position, as shown in dotted form in Figure 1,
; whereby to close the valve and confine the flow of water
through the pressure port 22 and speculum 12 into the
colon.
-- 7
1 329080
At the end of a fill interval and upon interrup-
tion in the flow of water through the inlet port 22 and the
pressure port 24, the hydrostatic head of water in the
patient is sufficient to flow outwardly through the specu-
lum together with waste matter thereby to open the valve 16
.~ by expansion or dilation of the liner 28 for return flow
~ through the valve and into the drain line D. Although not
shown, check valves are provided in the fill line L con~
;: nected to the inlet port to prevent return flow of water
from the speculum therethrough.
An important feature of the present invention
~ resides in the construction and arrangement of the speculum
.. 12 in establishing an open orifice through the anal canal
to obtain access to the central axis of the open inside
:~,
i diametex of the rectum, referred to as "centration to the
rectal lumen". The speculum 12 has an elongated tubular
' body 29. In the preferred form of speculum, the leading
end 20 terminates in a rounded, snub-nosed tip 30 having a
i; flattened end surface 31 of circular configuration at the
~. 20 very apex of the speculum and a generally elliptical sur-
;.,
face portion 32 which is formed by -the rotation of a
displaced conic section taken as a quadrant of an ellipse
.
... located with displacement about the longitudinal axis of
the speculum 12. The surface 32 merges into a moxe gra-
s dually tapered surface 33 which is relatively straight-
. walled and diverges outwardly and rearwardly to a
circumferential crown portion 34 which defines the maximum
:
'~ diameter of the speculum 12. A pair of diametrically
'Ji~ opposed eyelets or apertures 36 are formed through the wall
,- 30 thickness of the speculum, each having a diameter taken
~ laterally which is the diameter of the forwardmost portion
,~:
: - 8 -
.
. .
` 1 329080
of the central inside diameter of the speculum at the area
34. A diameter which has proven to be most effective in
. evacuating the colon is on the order of .550" to .7001'.
Larger diameters tend to drain too ~wiftly and create a
suction upon the mucosa while smaller diameters tend to
clog with waste matter. Location of the eyelets near the
. tip of the speculum is important to achieve alignment of
the eye of the speculum with the center of the inside
-.~ diameter of the rectum and minimizes occlusion of the
.~ 10 eyelets, which otherwise may cause undue pulling on the
:,
~ mucosa during the drain cycle, and better assure complete
J
and ~otal elimination of the waste material from the rec-
tum. Accordingly, each eyelet 36 includes a generally
semi-circular forward opening portion 38 which converges
rearwardly along inclined walls 39 to terminate in a rear-
ward arcuate portion 40. The eyelets are formed sym-
metrically with respect to the circumference of the leading
~i end 20 and each is provided with rounded edges which are
:~: flared or ramped outwardly away from the inner diameter of
the speculum into the outer diamet0r, for example, as
illustrated at 40 in Figure 6.
It will be noted from Figure 1 that the tubular
body 29 has an inner wall surface 42, and the leading end
similarly is formed with an inner wall surface of uniform
:~"
diameter which forms an uninterrupted continuation of th~
inner wall surface 42 until it converges into the rounded
.:
tip area 30, as illustrated in dotted form in Figure 1.
.i However, the external wall surface of the body increases in
thickness throughout the leading end to the maximum
diameter 34, then is graduaLly tapered in a rearward direc-
. tion until its termination in an anal stop ring 44 which is
. .
_ 9 _
1 329080
in the form of a collar in external surrounding relation to
the rearward end of the body. A connecting end portion 45
forms a tubular, slightly enlarged axial continuation of
the body 29. Connection of the speculum 12 to another
device may be accomplished by pressfi~ insertion of a
barbed end portion, such as, end portion 48 of the T-shaped
fitting 14, the end portion provided with external ribs or
barbs 49 which interengage with ribbed elements 46 on the
internal diameter of the connecting end portion 45.
Suitable interlocking keys and keyways between the coupling
- end portions, not shown, may be provided to assure proper
i~ orientation of the speculum and its eyelets 36 with respect
to the fitting 14 and the control valve 16.
When the speculum is to be inserted into the anal
canal of a patient, the tip 30 and its flattened end sur-
-face 31 is intended to prevent perforation of the mucosa
lining of the rectum which lie~ e!xactly opposite and per-
pendicular to the anal canal. When the speculum is
-i
inserted, there i8 the likelihoo~ of crossing over the
inside diameter of the rectum into contact with the deli-
cate mucosa lining of the rectal wall. The elliptical sur-
face 32 is the initial part o the speculum which enters
into the anal oriice by plying open the external
' sphincter, traversing the anal canal and then opening the
internal sphinctex. This type of dilation is made possible
by virtue of the variable rate of opening of the sphincter
muscles whirh the ellipse establishes with a rapid initial
entry and progre~sively slower as the ~phincter muscle i9
stretched until arriving at fuLl dilation. The rounded
~j~ 30 edges of the eyelets 36 minimize the possibility of pulling
; down or snagging hemorhoids by the speculum during removal
-- 10 --
'~
,:
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1 ~29080
at the end of a procedure. The forward rotation of the
eyelets 36 require that some dilation occur during inser-
. tion of the speculum and hence the requirement to make the
.~ rounded edges flare outwardly as at 40 from a point near
. the tip of the speculum to the full diameter of the specu-
lum body where the leading end surface 20 intersects the
maximum diameter 34. Further dilation of the internal and
:, external sphincters of the rectum is required in order to
. properly utilize a tapered anal lock created by the expan-
0 sion into the maximum diameter area 34 followed by gradual
taper along the body 29. Here, the tension of the inner
and outer sphincters of the anal orifice tend to advance
the speculum inwardly along the anal canal until
interrupted by the anal ring 44, and the ring 44 also ser-
ves to prevent leakage by virtue of the increased tension
of the internal sphincter on the larger end of the body.
~ Another important feature of the present invention
,. resides in the construction of the control valve 16 and its
'9 cooperative disposition in close proximity to the speculum
~ 20 12. The main body of the valve is defined by an outer
';~
thick-walled, rigid conduit or tube S0 having corresponding
connecting end portions 51 and 5~ at opposite ends thereof.
Each of the connecting end portions 51 and 52 includes an
external rib 54 diverging rearwardly from a relatively
.~,
thin-walled end cap 55 which extends from an internal
shoulder 56. The internal surface 58 of the tube 50 is of
uniform diameter between the shoulders 56, and the pressure
- port 24 extends through the wall of the tube into com
~,~ munication with the hollow interior o~ the tube at a point
`, 30 intermediately of the connecting ends 51 and 52. The liner
~8 is composed o a thin-walled elastomeric material and
~, -- 11 -
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1 329~80
"
may be a rubber or rubber-like material customarily
employed in surgical tubes. In colonic lavage operations
as described, the liner has a thickness on the order oE
0.010" and is sized such that its outer diameter
corresponds to the inner diameter 58 of the tube 50.
Opposite ends 60 o the tubular liner 28 extend beyond the
end caps 55 and are expanded and reversed upon themselves
s~
so as to be doubled over the end caps 55. When released,
the ends will effect tight-fitting sealed engagement with
:.-
the external surfaces of the end caps 55 whereby to form
the sealed annular space 26 between the inner diameter 58
;~ of the tube 50 and the liner.
:,;
, ~omplete sealing of the ends 60 of the liner is
:,
assured by the utilization of coupling portions 62 and 63,
~ the coupling poxtion 62 formed at one end of the fitting 14
,s~ opposite the barbed end 48 and the coupling 63 formed at
' one end of the barbed connecting end portion 18 for the
!~. drain line. Each coupling 62 and 63 includes an external
circumferential shoulder 64 which extends radially out-
. . . ~
wardly from tubular end 15 of the fitting 14, and the
shoulder or collar 64 is provided with an annular groove 66
`'s'~,
in facing reLation to the end cap 55 of the valve body 50
and is si~ed to r~quire close-fitting insertion of the end
`~ cap 55 and the surrounding end 60 of the liner 28 into the
~ grooYe- Elongated spring arms or detents 68 are disposed
-. in circumferentially spaced relation for extension in an
.~ .
~ axial direction away from the outer surface of the collar
`~ 62, each terminating in a radially inwardly directed end
69. The detents 68 possess limited resiliency so that when
~` 30 the end cap 55 is inserted into the groove 66, the ends 69
~f
' ''
~ - 12 -
.:~
1 329080
658~5-147
will have passed over the ribbed portlon 54 and into ~nap-flt
engagement wlth the radlal shoulder at the end of the rlb. The
coupllng portlon 63 ls correspondlngly formed to that of the
coupllng 62, and like parts are correspondlngly enumerated.
- It wlll be evldent that the only movable or functlon-
al part of the valve ls the elastlc llner 28 and whlch, by
virtue of itæ elastlclty, ls capable of movement between an
- open posltlon, as shown ln full, and a closed posltlon, as
`~ shown dott~d ln Flgure 1. Speclflcally, when pressure ln the
port 24 exceeds that from the speculum the llner 28 ls caused
to collapse inwardly along lts substantlal length as illus-
trated so as to effect a complete closure. Agaln, when the
pres~ure act:Lng agalnst the lnterlor of the llner 28 exceeds
that ln the pressure port 24, the llner wlll return to the
expanded, open posltlon so that th llquid and waste matter are
free to pass unob~tructed from the colon area through the
speculum 12 and valve 16. The connectlng end 18 ls lnserted
into a drain hose D of appropriate diameter to permlt removal
s; of the llquid and waste matter lnto a suitable receptacle, for
"
..~i .~.
~ 20 e~ample, in the manner descrlbed ln sald copendlng Canadlan
-~ patent &pplicatlon Serial No. 610,408 for "~OWEL CARE
. .,
APPARATUS".
`r~;~, In a colonic lavage operation, the ports 22 and 24
~'; are placed under pres~ure during the flll cycle wlth the pres-
':
, sure at the port 24 sllghtly higher than that in the port 22 so
that the liner 28 ls cau~ed to collapse and close the draln
llne. Accordlngly, fre~h water ls pumped under pressure from
the pump P vla the qpeculum 12 and into the colon. When the
pump P ls turned off at the end of the flll cycle, the water
pressure ln the ports 22 and 24 will
r
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1 329080
return to zero or atmospheric pressure with the result that
liquid and waste matter from the speculum 12 are at a
higher pressure and will open the valve 16 so as to be free
~i. to travel unobstructed through the valve 16 and drain line
; D. Preferably, the sequential fill and drain operations or
cycles are controlled by a timer and can be repeated any
.~ number of times as xequired to effect complete removal of
.~,
' waste matter from the colon. It will be appreciated that
, . .
x~ the speculum is conformable for use in other applications
7-
:- 10 requiring in]ection or delivery of a liquid into or from
,
the rectum; also, that the control valve assembly 16 is
. :
. readily adaptable for use in various applications which
, :,
re~uire an on-off valve sensitive to changes in differen~
tial pressure -to automatically open and close in response
~ to such changes.
.'~ It i9 to be understood that while a preferred form
", ~,
~r'~ of speculum and control valve have been set forth herein
that various modifications and changes may be mad~ without
, i".,
departing from the spirit and scope of the present inven-
tion as defined by the appended claims.
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