WO1994020059A1

WO1994020059A1 - Method for treating colic and constipation

Info

Publication number: WO1994020059A1
Application number: PCT/US1994/002430
Authority: WO
Inventors: Hélène M. BÉDARD
Original assignee: Nen, Inc.
Priority date: 1993-03-10
Filing date: 1994-03-07
Publication date: 1994-09-15
Also published as: AU6276494A

Abstract

The present invention provides a method for the treatment of colic, constipation and gas primarily in infants and also in adults. The method of the present invention comprises stimulating the anal sphincter muscles by directly massaging the same until gas and feces are expelled. Preferably the massaging is accomplished by inserting a device into the anal canal of an infant suffering from colic, constipation or gas. The device is moved inwardly and outwardly for a period of time and at a rate sufficient to stimulate the anal sphincter muscles. Such a method provides for the relief of colic in infants as well as for the relief of constipation and gas in infants under one year of age and adults. The device used in the present inventive method comprises a rod (1) having an insertable end (2) and a non-insertable end (4). In the preferred embodiment, the non-insertable end of the device may have a stopper (3) which may also function as a handle (6) or the device may have a separate stopper and handle. The stopper will prevent the insertion of the device too far into the anal canal, while the handle will allow for easier manipulation by the user.

Description


  
 



   METHOD FOR TREATING COLIC AND CONSTIPATION
Technical Field of the Invention
 The present invention is directed, in general, to a method for treating ailments of the gastrointestinal tract, particularly colic and constipation primarily in infants and similarly in adults.



  Background of the Invention
 Intestinal colic, usually referred to simply as "colic", is generally associated with infants, and is characterized by paroxysms of pain associated with a variety of causes such as swallowing of air, emotional upset or overfeeding.



   There is presently no cure for colic. Some methods of treating colic include having the infant use a pacifier, lying the infant on its stomach, lying the infant across an adult's knees, or use of a hot water bottle, sometimes associated with rubbing the infant on the back. Other treatments include the use of suppositories and gastrointestinal tubes. However, suppositories are often not recommended for infants under one year of age. The gastrointestinal tubes do not stimulate the sphincter muscles to expel gas or feces.



  Further, gastrointestinal tubes may become easily clogged.



   Constipation, gas and other related maladies require relief of some form. Constipation refers to a variety of changes including reduction in frequency of defecation, a constant sensation of rectal fullness with incomplete evacuation of feces and painful defecation due to hard stools or perianal pathology. However, constipation is a common complaint which is often the result of an expectation of "regularity" in bowel conscious individuals. Stools may be described as infrequent,  incomplete, or unduly hard. Unusual straining may be required to achieve defecation. The defecatory reflex is initiated by acute distension of the rectum, while concomitant relaxation of the internal and external anal sphincters permits evacuation of feces. Defecation may be consciously prevented by the voluntary contraction of the striated muscles of the pelvic diaphragm and external anal sphincter.



   In infants, constipation often begins to occur with the introduction of solid foods, usually around three months of age. Because infants do not consume roughage, exercise or consciously suppress defecation, a need exists for a method to provide temporary relief from constipation in infants. In adults, unlike infants, constipation is often the result of correctable causes, such as insufficient dietary roughage, lack of exercise, suppression of defecatory urges at inconvenient moments, inadequate allotment of time for full defecation and prolonged travel. Appropriate adjustment of these patterns should be all that is required for improvement.



  However, in the meantime, there is the need to provide temporary relief from constipation. In some cases a prescription of laxatives may be used. However, for those who cannot or prefer not to take prescription medication, the need exists for another method to provide temporary relief from constipation in adults.



   Thus, a need therefore exists for a simple, fastacting treatment for colic. A further need exists for a treatment for colic which can be used on infants under one year of age. The present invention provides a method for the temporary relief of colic and which may be repeated as often as necessary to relieve the infant of colic.



   A further need exists for a treatment for constipation and gas primarily in infants and also in adults who are unable or unwilling to ingest laxatives.  



  The present invention also provides a simple, fast-acting method for treating constipation particularly in infants without the need for ingesting any pharmaceutical products or making use of suppositories.



     Summarv    of the Invention
 The present invention provides a method for the treatment of colic, constipation and gas primarily in infants and also in adults. The method of the present invention comprises stimulating the anal sphincter muscles by directly massaging the same until gas and feces are expelled. Preferably the massaging is accomplished by inserting a device into the anal canal of an infant suffering from colic, constipation or gas. The device is moved inwardly and outwardly for a period of time and at a rate sufficient to stimulate the anal sphincter muscles. Such a method provides for the relief of colic in infants as well as for the relief of constipation and gas in infants under one year of age and adults.



   The device used in the present inventive method comprises a rod having an insertable end and a noninsertable end. In the preferred embodiment, the noninsertable end of the device may have a stopper which may also function as a handle or the device may have a separate stopper and handle. The stopper will prevent the insertion of the device too far into the anal canal, while the handle will allow for easier manipulation by the user.



   Other advantages of the present invention will become apparent from the following detailed description.



  Brief   DescriDtion    of the Drawings
 Figure 1 depicts a perspective view of an embodiment of the device used in the method of the present invention.  



   Figure 2 depicts a lateral view of an embodiment of the device used in the method of the present invention.



   Figure 3 depicts an end view of the insertable end of any embodiment of the device used in the method of the present invention.



   Figure 4 depicts an end view of the non-insertable end of an embodiment of the device used in the method of the present invention.



  Detailed Description of the Invention
 The invention may best be understood in the following detailed description.



   The method of the present invention requires insertion of a device into the anal canal and the subsequent movement of the device inwardly and outwardly while it is within the rectal cavity. The device is never completely removed from the anal canal during the process.



   In the preferred method of the present invention, the infant or adult is laid in a comfortable position, preferably on his back. It is recommended that plastic, a towel or some other material be placed underneath the infant's posterior to provide for easy clean-up. The infant's legs are preferably bent back out of the way such that, for example, his knees are held against his stomach exposing the individual's posterior.



   In a preferred embodiment, a lubricant is used to permit smooth insertion of the device into the anus. The lubricant preferably coats the insertable end of the device. The lubricant may be any pharmaceutically acceptable lubricant, such as glycerin or petroleum jelly. Petroleum jelly is preferred. The insertable end of the instrument should be pre-lubricated or a lubricant should be applied to the infant's anus before insertion of the device. After lubrication, the instrument can be easily inserted into the anal canal.  



   The instrument is inserted into the anal canal at an angle ranging from   0     to 450 from a plane parallel to the surface on which the infant is lying when the infant is in a horizontal position such that he is lying on his back. The outside ends of this range may be less desirable to the infant due to potential resistance when the device is inserted. Therefore, the preferable range is from about 100 to about 350 while the particularly preferred range is 280 to 320 because less resistance to the device is felt in the anal canal. When the instrument is inserted, the user should feel no resistance. If any resistance is felt, the instrument should be completely removed from the anal canal and gently re-inserted at a slightly different angle.



  Resistance is most likely to be felt at the outer extremes, such as   0     and 450, and less resistance is more likely to be achieved at the preferred angle of 280 to 320.



   After the device has been inserted into the anal canal, the device is moved inwardly and outwardly in the anal canal. However, the device is never completely removed from the anal canal until all gas or feces have been expelled. The method is generally performed continuously, for 1 to 4 minutes, preferably 2-3 minutes, after gas or feces have been expelled to be certain that all possible gas and feces have been removed. This method should be performed for a period of time at a rate sufficient to stimulate the sphincter muscles. It is generally not necessary to continue the movement of the device in such a manner for more than 30 minutes.

 

  However, on average it takes about 10 to 15 minutes to stimulate the sphincter muscles to expel gas and feces.



  Generally, the more often this method is performed on a particular infant the less time it takes to stimulate the sphincter muscles, thereby relieving the infant of gas and feces more rapidly. The range of time necessary to  perform this method may be anywhere from about 1 to 30 minutes. The time period involved, of course, is dependent upon the rate at which the device is moved inwardly and outwardly to achieve the desired muscle stimulations. A greater number of repetitions per minutes is not more desirable. Rather, gentle, slow stimulation of the muscles is preferred. Generally, the rate is such that the device is moved inwardly and outwardly at a rate of about 20 repetitions to about 60 repetitions per minute, while the preferred rate is about 25 to about 40 repetitions per minute.

  The movement of the device in this manner stimulates the anal sphincter muscles, causing the individual to expel feces and gas.



  The infant's familiarity with the method will also determine the rate at which it may be performed.



   This method provides for the temporary relief of colic, constipation and gas. In the case of colic, it may be necessary to repeat this method several times, as needed, during a day. Usually, the method needs to be performed 2 or 3 times a day. Since constipation does not recur as frequently as colic, the method may not need to be repeated as often, perhaps only on a daily basis.



   The instrument utilized in the method of the present invention may be any device which may be safely inserted into the anal canal and maneuvered inwardly and outwardly as required by the method. A preferred embodiment is depicted in Figures 1-4. With reference to Figures 1 and 2, it is preferable that the device be a rod 1 cylindrical in shape. The rod 1 should have a diameter small enough to fit into the anal canal, but wide enough to sufficiently stimulate the sphincter muscles without completely filling the anal canal. Generally, the diameter of the rod 1 will be about 1 millimeter to about 2 centimeters, and preferably,   ·    centimeter to   1%    centimeters, and most preferably,   ·    centimeters.  



   Preferably, the insertable end 2 of the rod 1 is rounded in some manner to prevent discomfort or injury when the rod 1 is inserted into the anal canal.



   To ensure that the rod 1 is not inserted too far into the anal canal, a stopping means 3 is preferably employed.



   The stopping means 3 may also act as a handle means or an additional handle means 6, as illustrated in
Figures 1 and 2, may be employed on the non-insertable end 4 of the rod 1 such that the stopping means 3 is located between the handle means 6 on the non-insertable end 4 and the insertable end 2.



   The stopping means 3, further illustrated in Figures 3 and 4, may be of any shape or size and is located on a portion of the rod 1 which is not inserted into the anal canal, the non-insertable end 4. The distance between the insertable end 2 and the stopping means 3 may be about   h    inch to 1 inches, preferably   h    inch to   1%    inches. If it is any longer, there is a risk of injury.



   The stopping means   3.    preferably has a series of passageways 5 to permit the passage of gas and feces when the sphincter muscles have been stimulated.



   The device may be made of a material which has a sufficiently solid construction to resist muscular contraction of the infant. Materials which may be used include glass, metal, plastic, wood, solid latex rubber or a polymer composition. Latex rubber and plastic are preferred because they have soft surfaces which can be easily cleaned do not and cause scratching of anal tissue.



   While the device used in the method may be reusable, it is preferable that the device be disposable, to avoid contact with any   --xcreted    feces and the bacteria or other contaminants associated therewith. If such device is not discarded, it should be thoroughly cleansed between uses, preferably with a disinfectant.  



   While the method of the present invention has been described in the context of relieving colic, constipation and gas in infants, the method may also be used for the relief of constipation and gas in adults. Note, however, that an adult may not be so easily positioned on his back as an infant is. Therefore, an adult may be placed in a semi-reclining position with the legs spread apart so that the anus may be accessed. If this is not feasible due to the individual's disabilities, the individual may be laid on his side with his knees bent inward toward his chest. Any other position may be used providing that the individual is comfortable and the anal canal can be accessed. If the individual is lying on his side or in any other position, an angle of insertion comparable to that described for infants should be used.



   The following examples further illustrate the method of treating colic and constipation of the present invention, but of course, should not be construed as in any way limiting its scope.



   EXAMPLE 1
 This example shows a preferred method for treating colic in infants.



   When a 3 month old infant began to show symptoms of intestinal colic, the infant was laid on her back on a towel and her diaper removed. While holding the infants legs up and out of the way against her chest, the device was inserted into the anal canal at a 300 angle to a plane parallel to the surface on which the infant was lying. The device was inserted only as far as the stopper. The device was then worked inwardly and outwardly for about 15 minutes to stimulate the anal sphincter muscles. Such stimulation caused the child to bear down resulting in the release of gas and feces. As a result of such relief, the child was no longer showing  symptoms of colic for a period of about   4    hours at which time this method was repeated with the same success.

 

   EXAMPLE 2
 The following is prophetic example of how the method of the present invention may be used for the treatment of colic and gas in disabled adults.



   The patient is laid in a comfortable position on his side with his knees bent slightly towards his chest. The device is then inserted into the anal canal at a   30     angle parallel to the plane extending along the individual's backside. The device is inserted no further than the stopper and worked inwardly and outwardly for about 9 minutes to stimulate the anal sphincter muscles.



  The patient will then defecate and relieve any gas buildup that may have been present.

Claims

What is claimed:

1. A method for the treatment of colic, constipation or gas in humans comprising the following steps: (a) inserting a device into the anal canal, said device being in the form of a rod having an insertable end and a non-insertable end, and having a diameter of sufficient size to enter the anal canal and stimulate the anal sphincter muscles; and (b) moving said device inwardly and outwardly of said canal for a period of time at a rate sufficient to stimulate the sphincter muscles.

2. The method of claim 1, wherein the human is an infant.

3. The method of claim 1, wherein said device is of sufficiently solid construction to resist muscular contractions of the human on which said device is inserted.

4. The method of claim 1, wherein said device is made of a material selected from the group consisting of glass, metal, plastic, wood, solid latex rubber and polymers.

5. The method of claim 1, wherein said device is made of molded plastic.

6. The method of claim 1, wherein said device is a rod having a diameter of about 1 millimeter to 2 centimeters.

7. The method of claim 6, wherein said rod has a diameter of about · centimeter to 1% centimeters.

8. The method of claim 7, wherein the diameter is centimeter.

9. The method of claim 1, wherein said device is disposable.

10. The method of claim 1, wherein said device is coated with a lubricant.

11. The method of claim 10, wherein said lubricant is selected from the group consisting of petroleum jelly and glycerin.

12. The method of claim 10, wherein the lubricant is petroleum jelly.

13. The method of claim 1, wherein said device is inserted into the anus at an angle of about 0 to 450 to the plane parallel to the surface on which the human is lying on his back.

14. The method of claim 1, wherein said device is inserted into the anus at an angle of about 100 to 300 to the plane parallel to the surface on which the human is lying on his back.

15. The method of claim 1, wherein said device is inserted into the anus at an angle of about 280 to 320 to the plane parallel to the surface on which the human is lying on his back.

16. The method of claim 1, wherein said period of time is about 1 minute to about 30 minutes.

17. The method of claim 1, wherein said period of time is about 10 to 15 minutes.

18. The method of claim 1, wherein said rate is 20 to 60 repetitions of said inwardly and outwardly movement per minute.

19. The method of claim 1, wherein said rate is 25 to 40 repetitions of said inwardly and outwardly movement per minute.

20. The method of claim 1, wherein said device has a stopping means located on a non-insertable end of the device.

21. The method of claim 1, wherein said device has a handle means on a non-insertable end of the device.

22. The method of claim 20, wherein the stopping means is located no more than 1 inches from an insertable end.

23. A method for the treatment of colic, constipation or gas in humans comprising the following steps: (a) inserting a device into the anal canal; said device comprising a rod having an insertable end and a non-insertable end, said insertable end having a diameter of sufficient size to enter the anal canal and stimulate the anal sphincter muscles, and a handle means located on said non-insertable end which operates as a stopping means; and (b) moving said device inwardly and outwardly of said canal for a period of time at a rate sufficient to stimulate the sphincter muscles.

24. A method for the treatment of colic, constipation or gas in a human comprising stimulating the anal sphincter muscles by directly massaging the same until gas and feces are expelled.