US2773502A - Device for treating alimentary tract - Google Patents

Description

Dec. 11, 1956 A. L. KASVLOW ET AL 7 5 DEVICE FOR TREATING ALIMENTARY TRACT Filed Dec. 21, 1953 11 fi cz slow James J Sapulo INVENTORS, BY I #110 rne Uited States PatentO DEVICE FOR TREATING ALIMENTARY TRACT Arthur L. Kaslow and James J. Saputo, Los Angeles, Calif.

Application December 21, 1953, Serial No. 399,304

6 Claims. (Cl. 128--260) This invention relates to means for treating parts of 'the alimentary tract with medicines.

, An object of the invention is to provide a device for use in treating various parts of the alimentary tract with medicines.

Another object of the invention is to provide means for localizing medication at a predetermined level in the alimentary tract and for treating a plurality of such levels all at the same time, but not necessarily with the same type of medicines.

A further object is to provide a medicinal pellet which may be directed under fluoroscopy to a desired level in the alimentary tract.

Another object of the invention is to provide medicinal pellets that are so compounded as to disintegrate in the alimentary tract at a predetermined and relatively'slow rate.

Further objects and advantages of the invention will become apparent from the following part of the specification wherein the details of construction and the manner of using certain embodiments of the invention are described with reference to the attached drawing which is for illustrative purposes only, and wherein:

Fig. l is a View diagrammatically illustrating the use of a device embodying the features of this invention;

Fig. 2 is a fragmentary detailed view, partly in section, of one form of the invention;

Fig. 3 is a cross-sectional view taken on line 33 of Fig. 2; and

Fig. 4 is a fragmentary detailed view, partly in section, of another form of the present invention.

' Referring to Fig. 1 of the drawing, reference numeral designates generally a device by which a plurality of medicinal pellets may be arranged in the alimentary tract for treatment 'of various parts of the tract. The device 10 includes a carrier shown as a waxed string 11 adapted to be prepositioned in the alimentary tract, and'of a length sufiicient to permit its proximal end to extend from the mouth of the patient, when the distal end ofthe string is in the lowest level in the alimentary tract where treatment is to be made. The string may be of a length'sufiicient to extend into the small bowel to provide medical treatment in the bowel. In the drawing the string 11 is shown as extending from the patients mouth 12 through the stomach 13 and duodenum 14.

An anchor pellet 15 is secured at one end of the string where it constitutes a weight to facilitate prepositioning of the string by pulling the string down through the esophogastrointestinal tract. The pellet 15 may be formed of a composition containing a medicine as will be explained in detail hereinafter, the composition being such as will disintegrate slowly in the body fluids," thus leaving the string free for removal of the string after treatment.

The string 11 carries a plurality of spaced apart beads, two of which are shown in detail at 17 and 18 in Fig. 2 of'the drawing. .These beads'are formed ofv amaterial which is not attacked by. body fluids, and for this purpose ina'y be formed of pearl, wood, glass, plastic, and like materials. Each bead is strung on the string 11 by passing the string through a hole 20 in the bead. Knots 21 are formed at spaced-apart points on the string, and these knots serve to retain the beads at intervals along the length of the string. For purposes which will presently appear, the beads are of graduated sizes with the largest thereof being nearest the anchor pellet 15. Thus, in Fig. 2 for example, the head 18 which is higher on the string 11 than the bead 17 vis of smaller diameter than the bead 17.

The beads 17 and 8 and others that may be provided on the string 11 as required, function as stop elements to position medicinal pellets along the'length of the string. The device illustrated in Fig. 1 includes six medicinal pellets, in addition to the anchor pellet 15, which are adapted tobe strung on the prepositioned carrier from its proximal end. These pellets are numbered consecutively on the drawing from 23 to 28 inclusive, with the pellet nearest the anchor pellet 15 at the distal end of the carrier being numbered 23. Referring to Fig. 2, wherein pellets 26 and 27 are illustrated in cross-section, it will'be noted that the pellet 26 has a bore 30 through the longitudinal axis thereof. The diameter of the bore 30 is smaller than that of the bead 17 and thus the pellet 26 will not pass the bead 17, when the pellet is strung. The bore 30 is, however, larger in diameter than the bead 18 which is higher on the string. Thus, the pellet 26 will pass all of the beads on the string 11 until it is stopped by the bead 17. In a like manner, the diameter of a bore 31 in the pellet 27 is smaller than the diameter of thebead 18, but larger than the bead next higher on the string whereby when the pellet 27 is strung, it will pass all beads until it reaches and is stopped by the bead 18. Thus, the position at which a pellet is stopped along the length of the string is dependent upon the size of the bore of the pellet.

Although the pellets 26 and 27 are shown as having uniform cylindrical bores, the bore of a pellet may be tapered as illustrated in Fig. 4, or it may be otherwise suitably shaped, whereby the beads easily enter the bores of the pellets as the pellets are strung. The pellets may, of course, be of any size that may be swallowed; however, we have found that pellets of approximately /1 inch in length and approximately inch in diameter provide a substantial treatment period and yet are not too large to cause appreciable discomfort during deglutition thereof.

Although the pellets are compounded in a manner which causes them to disintegrate very slowly, it sometimes becomes necessary to continue medication after the pellets are spent. In such case, additional pellets may be strung on the string 1 and swallowed withoutremoving the string from its position in the alimentary tract. The level at which any of'these additional pellets will become located in the tract is predetermined by the size of the bore in such pellet, i. e., the pellet will travel down the alimentary tract until it is stopped by a head of a diameter larger than that of the bore of the pellet.

With the device of this invention, a patient may receive localized medications at several spaced-apart points in the alimentary tract, and in cases where it is found to be necessary or desirable each of these locations may be treated with a medicine that is different in type and in its action from that being used to treat another location in the tract. Each pellet may contain a medicine that is particularly suited for treating a given zone in the tract. Thus, for example, in the esophagus, the pellet 28 may contain penicillin, pellet 27terramycin, and pellet 26-procaine anesthetic. A pellet containing aluminum hydroxide may be employed at 25 for treat- .rnent-in the stomach 13, while at '24 the pellet may 0011* 3 tain procaine anesthetic. In the duodenum the pellet 23 may contain magnesium sulphate, and the anchor pellet may be formed with phenobarbital as a constituent thereof. i

In cases where it is desired to position a pellet at an exact location in the alimentary tract the pellets may contain a substance such as barium sulphate, for example, which is opaque to X-rays. Such pellets may be viewed fluoroscopically and their position in the alimentary tract adjusted by raising or lowering the string 11 as required. After the pellets have been properly positioned, the string 11 is secured in place in any suitable manner as by knotting the string at a measured distance from a given pellet and slipping the string between adjacent teeth of the patient so that the knot will hold the string in place, or the string may be tied to a strip of tape applied to the face ofthe patient, as illustrated at 33.

In addition to a medicine and an X-ray opaque component, the composition for forming the pellets includes a base material having constituents which control the rate at which the pellets will disintegrate. In general, where prolonged medication is desired, the amount of retarding agent in the base material will be increased, or should rapid disintegration of the pellet be needed, the amount of agents that swell and break down will be increased. Thus, a pellet useful in this invention may be formed with a base material comprising a wax, fatty acid, petrolatum, and a hydrophilic swelling agent. A suitable wax, for example, is carnauba wax, which acts as a carrier and is resistant to acid secretions in the stomach. Of the fatty acids, stearic acid is the most palatable and in the present invention it functions primarily in the base material as a carrier. The petrolatum (e. g. petroleum jelly) functions to prevent cracking, and gives the pellet a certain amount of flexibility. This ingredient also acts to retard the rate at which the pellets break up or disintegrate, and also causes the pellets to disintegrate at a substantially even or constant rate. The hydrophilic agent may consist of agar-agar or other gums that swell and break down in water, or it may include such agents as elm bark, starch, sodium chloride, bran, and other substances that will assist in tending to disintegrate the pellet.

A suitable base material composition of the above character may be compounded by mixing the following constituents in the indicated proportions by weight, namely: about 11 parts of carnauba wax, 11 parts of powdered stearic acid, 1 part of petroleum jelly, and 12 parts of powdered agar.

When the base material set forth in the example above is mixed with aluminum hydroxide as a medicine, and in the proportions of approximately one part of medicine to two parts of base material, and with approximately two per cent by weight of barium sulphate for X-ray diagnosis; the pellets formed from such mixture in the size referred to hereinabove will be found to disintegrate in about five hours in distilled water at a temperature of approximately 100 F.

To prepare the composition which will be used to form the pellets, the fatty acid, wax, and petroleum jelly may be melted together as in a stainless steel container over a water bath. While this mixture is still in a molten state the aluminum hydroxide, agar, and the barium sulphate may be added. The mixture should then be stirred thoroughly and poured into pans immediately and then allowed to cool and set preferably for a period of at least ten hours, to eliminate air bubbles and to obtain a complete dispersion of the drug, barium sulphate and agar. The material sets very hard. When it is desired to form pellets therefrom, the material is melted at a temperature of from about 90 to 94 C., and constantly agitated to prevent the agar, drug and barium sulphate from settling out. The pellets are then formed by dipping a metal rod into the melted mixture; thereafter removing the rod and allowing the layer thus formed on the rod -to cool thoroughly. After this first layer is cooled,'the rod is 4 again dipped into the melted mixture to form a second layer.

In the drawing, the pellets are illustrated as having an inner sleeve 35 and an outer portion 36. The inner sleeve 35 may be formed from a substance which is not readily attacked by body fluids, and for this purpose it may be formed from a mixture, for example, of 50% carnauba wax and 50% stearic acid. This mixture will set hard and will dissolve very slowly as compared to the medicated mixture previously described. Thus, in forming th first layer of the pellet the rod on which the pellet is formed is first dipped into a mixture of this type and thereafter the outer layers are formed by dipping the rod into the medicated mixture as explained above. By forming the inner layer of a pellet with a composition that is very slowly broken up as compared with the outer layers of the pellet, the bore of the pellet will not become enlarged before the medicine is spent, and thus the pellet will not move to a lower zone in the alimentary tract prior to the time its medicinal layer is spent. Of course, the sleeve 35 may be formed from materials such as plastic and the like, which are unaffected; however, sleeves which eventually do disintegrate are preferred, since after treatment removal of the sleeves will be unnecessary. In this connection, it should be noted that the anchor pellet 15 may also be formed of a mixture which disintegrates very slowly in body fluids so that it need not be removed after treatment.

In the modification shown in Fig. 4, the string 40 for holding the pellets 41 and 42 is gradually tapered and may be made of a suitable plastic material. In this form of the invention, the pellets travel down the length of the string until they reach a section having a diameter large enough to prevent further downward movement of the pellets. When the pellets have completely disintegrated, the string 40 may then be removed easily without causing any discomfort to the patient.

Various modifications may suggest themselves to those skilled in the art, without departing from the spirit of our invention, and, hence, we do not wish to be restricted to the specific forms shown or uses mentioned, except to the extent indicated in the appended claims.

We claim:

1. In a device for positioning medicine at a predetermined zone in the alimentary tract; a weighted carrier; a medicinal pellet having a hole therethrough, whereby said pellet may be strung on said carrier; and means associated with said carrier having coaction with a strung pellet to determine its location on the carrier depending upon the diameter of said hole.

2. In a device for positioning medicine at a predetermined zone in the alimentary tract: an elongate carrier having a proximal end and a. distal end; and a plurality of medicinal pellets, each of said pellets having a hole therethrough, the size of the hole in any one pellet being different from that of any other pellet, and said pellets being strung on said carrier from its proximal end and maintained in spaced-apart relation with the pellets arranged in the order of their hole sizes and with that pellet having largest hole size being located nearest the distal end of said carrier.

3. In a. device for positioning medicine at a predetermined zone in the alimentary tract: a string; weight means fixed at one end of said string; a plurality of stops spaced along the length of said string, said stops being graduated in size and with the largest thereof being nearest said weight means; and a plurality of pellets containing medicine strung on said string and being held by said stops from travel along the length of said string.

4. A device according to claim 2, wherein the carrier comprises: a gradually tapered string of larger diameter at one end than at the other end thereof; and the holes of said pellets are of smaller diameter than said one end and oflarger diameter :than said other end of said string. 5. A device according. to claim 2, wherein the carrier 6 comprises a gradually tapered string of larger diameter 2,512,192 Yen et al June 20, 1950 at one end than at the other end thereof, whereby pellets 2,594,093 Thompson Apr. 22, 1952 having different sized holes will be stopped at spaced in- FOREIGN DATENTS tervals on said string. 1

6. A device according to claim 2, wherein the carrier 5 949,237 France 1949 comprises a gradually tapered string of larger diameter OTHER REFERENCES at one end than at the other end thereof; and the holes of said pellets are tapered to correspond with spaced sections of said string.

American Journal of Clinical Pathology, vol. 19, No. 9, September 1949, pp. 891, 892. (Copy available in 10 Scientific Library.)

References Cited in the file of this patent UNITED STATES PATENTS 2,483,098 Millard Sept. 27, 1949

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