|Publication number||US3766920 A|
|Publication date||Oct 23, 1973|
|Filing date||Jul 21, 1971|
|Priority date||Jul 21, 1971|
|Also published as||CA994195A, CA994195A1, DE2235186A1|
|Publication number||US 3766920 A, US 3766920A, US-A-3766920, US3766920 A, US3766920A|
|Original Assignee||Ezem Co|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (7), Referenced by (41), Classifications (17), Legal Events (2)|
|External Links: USPTO, USPTO Assignment, Espacenet|
Greene ENEMATA ADMINISTERING DEVICE  Inventor: Franklin R. Greene, Flushing, NY.
 Assignee: E-Z-EM Company, Inc., Westbury,
 Filed: July 21, 1971  Appl. No.: 164,660
3,407,817 10/1968 Galleher 128/349 8 Primary Examiner-Richard A. Gaudet Assistant Examiner-J. Yasko Att0rneyJames E. Ryder et al.
 ABSTRACT A smooth, flexible enema tip having an inflatable balloon mounted on the stem behind the exit port from the tip. A limited volume, flexible, hand distendable air reservoir is connected to the balloon-like retention ring so that operator compression of the reservoir will inflate the ring. The reservoir is filled with a resilient sponge so that the reservoir will snap back to its full volume shape once operator pressure is removed and thus normally deflate the ring. A soft, flexible, plastic annular retention pad is mounted for axial movement along the enema stem which terminates on the tip. This pad cooperates with the balloon to hold the balloon in position.
1 Claim, 2 Drawing Figures ENEMATA ADMINISTERING DEVICE This invention relates in general to a device for administering enamata and more particularly to one that provides an improved degree of safety for the patient together with convenience and retention features.
BACKGROUND OF THE INVENTION Although a variety of devices are known and have been proposed for the administration of enemas and particularly for the administration of a barium sulfate enema as part of radiological examination, these devices ignore and perhaps even sacrifice the comfort and safety of the patient to cost consideration or to considerations of convenience for the doctor. For example, it
is known to provide an expandable annular balloon vide an enemata administration device that will provide as great a degree of increased comfort for the patient as is possible.
It is a further purpose of this invention to provide this increased safety and increasedcomfort in a device that includes convenience features for the doctor and that is sufficiently simple and inexpensive so that a disposal device is provided at a cost which makes it feasible and likely that the improved safety and comfort features will gain acceptance.
BRIEF DESCRIPTION OF THE INVENTION In brief, this invention involves a smooth, flexible enema tip having an inflatable balloon mounted on the stem behind the exit port from thetip. A limited volume, flexible, hand distendable air reservoir is connected to the balloon-like retention ring so that operator compression of the reservoir will inflate the ring. The reservoir is tilled with a resilient sponge so that the reservoir will snap back to its full volume shape once operator pressure is removed and thus normally deflate the ring. A soft, flexible, plastic annular retention pad is mounted for axial movement along the enema stem which terminates on the tip. This pad cooperates with the balloon to hold the balloon in position.
BRIEF DESCRIPTION OF THE DRAWINGS The drawings, both of which are the same embodiment are:
FIG. 1 is a perspective view of an embodiment of this invention.
FIG. 2 is a view in slightly larger scale than FIG. 1 of the forward portion of the FIG. 1 device partially in perspective and partially in cross-section and including a view in cross-section of the air reservoir unit.
DESCRIPTION OF THE PREFERRED EMBODIMENTS As shown in the Figures, this invention is in an enemata structure. The component parts incoude a smooth, flexible, plastic tubular enema stem 12 having a tip portion 14 for insertion into a patient and a series of concentric undulations l6 behind the tip 14. An inflatable expandable thin-wall balloon-like torroidal retention element 18 is affixed onto the stem 12 immediately behind the tip portion 14. A flexible, limited volume air reservoir 20 is in communication with the interior of this torroidal retention element 18 by way of a flexible tube 22. One end of the tube 22 is connected to the reservoir stem 24 by being stretched over the reservoir stem 24 and retained thereon by friction. This permits the reservoir 20 to be disconnected from the tube 22 at the desire of the doctor so that the doctor can control inflation of the retention device 18 through some other air source. The doctor may wish to do this in particular cases where, for example, he wishes to increase the amount of inflation over the predetermined maximum amount that is available with this enclosed limited volume reservoir 20.
The air reservoir 20 is an enclosed space which can be compressed by the user so that the air in the space is forced into the retention device 18. Because the air reservoir 20 is an enclosed volume, it limits the amount of expansion of the retention device 18. This limitation of the expansion of the retention device 18 is very important from a safety point of view. Over inflation of these retention devices 18 can damage the tissues of the patient, rupture internal walls and, in rare cases, even result in killing a patient. A resilient plastic sponge 25 substantially fills the interior of the reservoir 20 .so that when hand pressure of the reservoir is released, the sponge 25 will spring back to its normal shape and expand the walls of the reservoir 20. As a consequence, the air in the retention device 18 will be drawn back into the reservoir.
Thus, this reservoir 20 not only prevents over inflation of the retention balloon 18, but also assures that the balloon l8 deflates as soon as the doctor or his assistant releases his hold on the air reservoir. A clip 26 is mounted on the reservoir stem 24 so that the retention balloon 18 can be maintained in an inflated state even after pressure on the air reservoir 20 is released. This design means that the clip 26 purposely has to be moved after the balloon 18 inflation, into the position where it pinches the stem 24 and holds the balloon l8 inflated. Thus the balloon 18 is kept inflated only on purpose and after a chance is had to be warned of excessive patient discomfort or other abnormal reaction.
A soft flexible plastic retention ring 28 is mounted for movement along the stem 12. The retention ring 28 is a deformable plastic disc-like device that fits on the troughs of the undulations 16 but that can be forced over the ridges of the undulations 16 so that it can be forced forward and back over the ridges. The purpose of the retention ring is so that when the device is inserted into the patient, the retention ring can be pushed forward against the patients anus to assure that the retention balloon 18 is properly seated against the internal sphincter muscle. The retention ring 28 has a thin vinyl casing 28c containing an annulus of resilient plas tic foam 28f. The soft foam 28f is easily deformable so as to provide a soft cushion for the patient. The vinyl casing 28c stretches sufficiently so that the ring 28 can be manually forced over the ridges of the undulations 16. Yet the vinyl casing resists stretching sufficiently so that it can operate as part of the retention arrangement without slipping back over the ridges. Because the retention ring 28 is annular it cannot fall off or slip off the stem 12.
A flexible tube 30 connected to the back end of the enema stem 12 permits connection to a reservoir (not shown), which reservoir may contain, for example, a barium sulphate suspension. A clip 32 on the flexible tube 30 permits a convenience of detaching the flexible tube 30 from the reservoir after the fluid has been administered to the patient so that the patient can be moved, or can move himself, to a toilet for convenient elimination.
An airway or air tube 34 is a small flexible tube that passes through an opening 36 in the stem 12 and then through the interior of the stem 12 to the front opening of the tip 14. This airway 34 permits air to be administered by the doctor when desired and to the extent necessary. A clip 38 on the airway permits closing off the airway when necessary or desired. Because the airway 34 passes through the interior of the tubular stem 12, there is no break in the smooth surface of the stem 12 and the tip 14. This further enhances patient comfort.
What is claimed is:
l. A self-retaining rectal catheter for barium enemata comprising;
a flexible plastic stem having an exit port,
a normally deflated inflatable annular retention balloon mounted behind said exit port of said stem,
a rentention ring mounted for axial movement on said stem and positioned behind said balloon,
an air reservoir,
a first conduit in communication with said retention balloon,
a second conduit in communication with said air reservoir,
a detachable coupling between said first and said second conduits,
said air reservoir and said retention balloon comprising a closed system when said coupling is made, said closed system having a fixed and limited quantity of air therein,
said air reservoir being a readily compressible pourous resilient sponge substantially filling said reservoir and having a normal uncompressed state and a compressed state, said reservoir tending to restore itself to said normal uncompressed state when compresive pressure is removed from said reservoir,
said air reservoir when compressed forcing air into said retention balloon, the quantity of air forced into said retention balloon by the compression of said air reservoir being sufficient to inflate said balloon,
said air reservoir in said uncompressed state providing sufficient volume to accept a quantity of air from said balloon when said balloon is in its inflated state to cause said balloon to collapse to its normal deflated state,
the only source of air for inflating said balloon when said coupling is made being the fixed quantity of air in said reservoir when said reservoir is in its normal uncompressed state,
said coupling when detached freeing said first conduit for connection to a source of air other than said reservoir, and
a manually actuable clamp on one of said conduits, said clamp having a closed state and an open state, said clamp when in said closed state shutting off communication between said balloon and said reservoir to permit maintaining said balloon in an in flated state after said balloon has been inflated by compression of said reservoir,
said manually actuable clamp being the sole means of closing off communication between said reservoir and said balloon,
said balloon having a single exit/entrance port and said reservoir having a single entrance/exit port, both of said entrance/exit ports being unobstructed during all states of inflation and deflation of said balloon and during all states of expansion and compression of said reservoir.
|Cited Patent||Filing date||Publication date||Applicant||Title|
|US2457244 *||Jun 22, 1943||Dec 28, 1948||Otis F Lamson||Medical appliance for control of enemata|
|US3009459 *||Sep 12, 1957||Nov 21, 1961||Henning Ruben||Apparatus for artificial respiration|
|US3154078 *||Feb 12, 1962||Oct 27, 1964||Jr Edward O Goodrich||Catheter combination|
|US3176691 *||May 8, 1963||Apr 6, 1965||Kendall & Co||Catheter tubing clamp|
|US3407817 *||Jul 26, 1965||Oct 29, 1968||Air Reduction Inc||Catheter with cuff inflater and indicator|
|US3459175 *||Apr 8, 1966||Aug 5, 1969||Miller Roscoe E||Medical device for control of enemata|
|US3572340 *||Jan 11, 1968||Mar 23, 1971||Kendall & Co||Suction drainage device|
|Citing Patent||Filing date||Publication date||Applicant||Title|
|US3927672 *||Sep 12, 1973||Dec 23, 1975||Rosenblum Saul A||Device for sealing body cavity during introduction of fluid to or extraction of fluid from said cavity|
|US4280501 *||Jun 13, 1979||Jul 28, 1981||Foderick John W||Inflatable catheter means and method|
|US4391280 *||Nov 30, 1981||Jul 5, 1983||Miller Roscoe E||Enema apparata improvements relating to double contrast studies|
|US4583983 *||Oct 25, 1983||Apr 22, 1986||Einhorn Carol J||Female urinary drainage device|
|US4834068 *||Mar 18, 1988||May 30, 1989||Gottesman James E||Barrier shield method and apparatus for optical-medical devices|
|US6048331 *||Dec 18, 1997||Apr 11, 2000||Embol-X, Inc.||Cardioplegia occluder|
|US6468245||Nov 27, 1997||Oct 22, 2002||Colorplast A/S||Irrigation device|
|US7722583||Apr 28, 2006||May 25, 2010||Hollister Incorporated||Bowel management system and waste collection bag therefor|
|US7914505||Apr 11, 2003||Mar 29, 2011||Coloplast A/S||Irrigation system|
|US8016816||Aug 28, 2004||Sep 13, 2011||Convatec Technologies Inc.||Fecal management appliance and method and apparatus for introducing same|
|US8231581||Jan 25, 2011||Jul 31, 2012||Portaero, Inc.||Enhanced pneumostoma management device and methods for treatment of chronic obstructive pulmonary disease|
|US8323255||Feb 11, 2009||Dec 4, 2012||Hollister Incorporated||Bowel management system|
|US8347880||Jan 8, 2013||Potaero, Inc.||Pneumostoma management system with secretion management features for treatment of chronic obstructive pulmonary disease|
|US8347881||Jan 8, 2010||Jan 8, 2013||Portaero, Inc.||Pneumostoma management device with integrated patency sensor and method|
|US8348906||Jan 8, 2013||Portaero, Inc.||Aspirator for pneumostoma management|
|US8365722||Feb 18, 2009||Feb 5, 2013||Portaero, Inc.||Multi-layer pneumostoma management system and methods for treatment of chronic obstructive pulmonary disease|
|US8430094||Feb 18, 2009||Apr 30, 2013||Portaero, Inc.||Flexible pneumostoma management system and methods for treatment of chronic obstructive pulmonary disease|
|US8453637||Jun 4, 2013||Portaero, Inc.||Pneumostoma management system for treatment of chronic obstructive pulmonary disease|
|US8453638||Feb 18, 2009||Jun 4, 2013||Portaero, Inc.||One-piece pneumostoma management system and methods for treatment of chronic obstructive pulmonary disease|
|US8464708||Feb 18, 2009||Jun 18, 2013||Portaero, Inc.||Pneumostoma management system having a cosmetic and/or protective cover|
|US8474449||Feb 18, 2009||Jul 2, 2013||Portaero, Inc.||Variable length pneumostoma management system for treatment of chronic obstructive pulmonary disease|
|US8475389||Jun 8, 2010||Jul 2, 2013||Portaero, Inc.||Methods and devices for assessment of pneumostoma function|
|US8506577||Jul 6, 2012||Aug 13, 2013||Portaero, Inc.||Two-phase surgical procedure for creating a pneumostoma to treat chronic obstructive pulmonary disease|
|US8518053||Feb 11, 2010||Aug 27, 2013||Portaero, Inc.||Surgical instruments for creating a pneumostoma and treating chronic obstructive pulmonary disease|
|US8663180||Jan 21, 2008||Mar 4, 2014||Coloplast A/S||Irrigation system with a pump|
|US8801683||Apr 29, 2011||Aug 12, 2014||Hollister Incorporated||Bowel management system|
|US8827970||Aug 2, 2011||Sep 9, 2014||Convatec Inc.||Fecal management appliance and method and apparatus for introducing same|
|US20050054996 *||Aug 28, 2004||Mar 10, 2005||Gregory Christopher C.||Fecal management appliance and method and apparatus for introducing same|
|US20060129135 *||Apr 11, 2003||Jun 15, 2006||Peter Moeller-Jensen||Irrigation system|
|US20060189951 *||Apr 28, 2006||Aug 24, 2006||Kim Jae H||Bowel management system and waste collection bag therefor|
|US20080262447 *||Apr 28, 2006||Oct 23, 2008||Hollister Incorporated||Bowel management system and waste collection bag therefor|
|US20090030386 *||Oct 3, 2008||Jan 29, 2009||Hollister Incorporated||Bowel management system and waste collection bag therefor|
|US20090030387 *||Oct 3, 2008||Jan 29, 2009||Hollister Incorporated||Bowel management system and waste collection bag therefor|
|US20090205647 *||Feb 18, 2009||Aug 20, 2009||Portaero, Inc.||Pneumostoma management system having a cosmetic and/or protective cover|
|US20090205658 *||Feb 18, 2009||Aug 20, 2009||Portaero, Inc.||Devices and methods for delivery of a therapeutic agent through a pneumostoma|
|US20090209917 *||Feb 18, 2009||Aug 20, 2009||Portaero, Inc.||Aspirator for pneumostoma management|
|US20100063436 *||Jan 21, 2008||Mar 11, 2010||Coloplast A/S||Individually Positionable Pump System|
|US20100174252 *||Jan 21, 2008||Jul 8, 2010||Coloplast A/S||Irrigation system with a pump|
|US20110180064 *||Jul 28, 2011||Portaero, Inc.||Methods and devices for follow-up care and treatment of a pneumstoma|
|EP2242529A2 *||Feb 18, 2009||Oct 27, 2010||Portaero, Inc.||Surgical instruments for creating a pneumostoma and treating chronic obstructive pulmonary disease|
|WO1989008422A1 *||Mar 15, 1989||Sep 21, 1989||Vance Products Inc||Barrier shield for optical-medical devices|
|U.S. Classification||604/97.1, 604/912|
|International Classification||A61F2/958, A61M31/00, A61M25/02, A61M3/02|
|Cooperative Classification||A61M31/00, A61M25/02, A61M3/027, A61M3/0295, A61M25/1002, A61M2025/0266|
|European Classification||A61M3/02F, A61M25/10A, A61M3/02H8, A61M31/00, A61M25/02|
|Apr 23, 1984||AS02||Assignment of assignor's interest|
Owner name: E-Z-EM COMPANY, INC., A CORP OF NEW YORK
Owner name: E-Z-EM, INC., 7 PORTLAND AVENUE, WESTBURY, NEW YOR
Effective date: 19840329
|Apr 23, 1984||AS||Assignment|
Owner name: E-Z-EM, INC., 7 PORTLAND AVENUE, WESTBURY, NEW YOR
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST.;ASSIGNOR:E-Z-EM COMPANY, INC., A CORP OF NEW YORK;REEL/FRAME:004266/0754
Effective date: 19840329
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:E-Z-EM COMPANY, INC., A CORP OF NEW YORK;REEL/FRAME:004266/0754
Owner name: E-Z-EM, INC.,NEW YORK