US3467103A

US3467103A - Inflatable bag catheter

Info

Publication number: US3467103A
Application number: US542269A
Authority: US
Inventors: John R Mckinstry; Myron C Monck; Robert L Hayes
Original assignee: BF Goodrich Corp
Current assignee: Goodrich Corp
Priority date: 1966-04-13
Filing date: 1966-04-13
Publication date: 1969-09-16
Anticipated expiration: 1986-09-16

Description

Sept. 16, 1969 )i R, MoKmsTRY ET AL 3,467,103

INFLATABLE BAG CATHETER Filed April l5. 1966 United States Patent O U.S. Cl. 12S-349 4 Claims ABSTRACT F THE DISCLOSURE An inflatable bag catheter is provided for use by physicians to drain fluids from the internal organs of patients. The catheter comprises a thin-walled drainage tube formed of flexible vinyl chloride polymer and an inflatable retention bag formed of elastic rubber and may have a flexible inflation arm formed of elastic rubber. The inner surfaces of the elastic rubber bag and the inner surfaces of the a elastic rubber inflation arm are halogenated to provide an acceptable bonding of the rubber to the vinyl chloride polymer.

This invention relates to catheters and pertains more particularly to inflatable bag catheters.

Inflatable bag catheters have been used commonly by physicians for many years to drain internal organs of patients. Such catheters are comprised of a thin-walled flexible hollow drainage tube provided with one or more lateral openings in its distal end to allow fluid contained in an internal organ into which the catheter is inserted to be drawn into the hollow tube and be expelled at the proximal end of the tube. The catheter also is provided with a portion adjacent the distal end thereof that is capable of being inflated into a bulbous shape for retaining the catheter in position once the catheter has been inserted into the internal organ to be drained. The inflatable bag is inflated through an inflation tube that connects with the inflatable bag and extends to the proximal end of the catheter. The inflation tube generally terminates exteriorly of the drainage tube at the proximal end of the catheter as a lateral inflation arm that is provided at its mouth with a plug or valve which maintains the mouth of the inflation arm normally closed.

In using the catheter, the distal end of the catheter first is inserted into the organ to be drained. Thereafter, the inflatable retention bag of the catheter is inflated by introducing a required amount of inllating fluid (sterile water normally being used) into the inflation arm, usually through use of a hypodermic syringe inserted through the plug in the inflation arm when a plug is used or when a valve is employed by means of a syringe provided with a tip capable of opening the valve in the inflation arm. Also, it recently has been proposed to confine a measured amount of inllating fluid in the inflation arm of the catheter which upon being released from confinement will flow down the inflation tube and cause the inflatable retention fbag to expand, thereby eliminating the necessity of exteriorly introducing inflating fluid into the inflation arm. When it is desired to remove the catheter from the body of the patient, the inflating fluid which has been introduced into the catheter is withdrawn by introducing a hypodermic syringe or valve-opening syringe into the inflation arm and by withdrawing fluid through use of the syringe until the retention bag is deflated sufllciently to permit the catheter to be withdrawn from the patient without undue discomfort.

For many years such catheters were made from natural rubber latex by a latex dip procedure. However, since the catheter may remain inserted in the patient for several days and since natural rubber has a tendency to irritate the ICC body tissue with which the natural rubber is in contact when the catheter must remain inserted for several days in the patient, it was proposed that the catheter be formed of a vinyl chloride polymer which has less tendency to irritate lbody tissue after prolonged contact therewith than does natural rubber. However, since vinyl chloride polymers are relatively inelastic, catheters formed of vinyl chloride polymers necessarily have been limited to the non-inflatable type.

The present invention provides an inflatable -bag catheter in which the drainage tube or lumen of the catheter is formed of a vinyl chloride polymer and the inflatable retention Ibag of the catheter is formed of an elastic rubber such as natural rubber. The novel catheter of this invention will be more fully understood from the following descriptions of two embodiments of the invention and from the drawings, in which:

FIG. l is an elevation view, partly broken away and in section, of an inflatable bag catheter embodying the present invention;

FIG. 2 is an enlarged elevation view, partly broken away and in section, of the inflation arm of the catheter shown in FIG. 1;

FIG. 3 is an enlarged elevation view, partly broken away and in section, of the inflation sleeve or bag of the catheter shown in FIG. l; and

FIG. 4 is an elevation view, partly broken away and in section, of a second inflatable bag catheter embodying the present invention.

Referring to the catheter shown in FIG. l, the inflatable bag catheter 10 is comprised of an elongated flexible thin-walled hollow drainage tube 11 made of a plasticized vinyl chloride polymer and flared at its proximal end 12 to facilitate the insertion of a connector tube and rounded at its distal end 13 into a rounded closed tip 14. The distal end 13 ofthe catheter 10 is provided with one or more lateral openings 15 connecting into the interior of drainage tube 11 to permit fluid in the internal cavity to be drained to enter the drainage tube 11, travel the length of drainage tube 11 and be expelled through the opening in the proximal end of the drainage tube 11.

Adjacent the distal end 13 of the catheter 10, a thinwalled elastic rubber sleeve or bag 16 is adhered along its

marginal zones

17, 17 by means of adhesive 18 to the exterior surface of the drainage tube 11 to form fluidtight seals. The central zone 19 of the sleeve 16 is unattached to the drainage tube 11 so that the central zone 19 can be expanded by inflating fluid into a bulbous contour (such as is shown in phantom in FIG. l) in order to prevent the catheter from becoming inadvertently withdrawn from the patient. A flexible vinyl chloride polymer inflation tube 20 is disposed within drainage tube 11 and opens at its distal end into the space formed between the central zone 19 of the sleeve 16 and the exterior surface of the drainage tube 11. The inflation tube 19 emerges through the wall of drainage tube 11 and extends exteriorly of drainage tube 11 a distance sulllcient to form a nipple 21 to which the inflation arm 22 of the catheter can be adhered with adhesive 23. The inflation arm 22 (which is offset from the proximal end of the drainage tube 11) is shown to be formed of an elastic rubber such as natural rubber so that a predetermined quantity of inflating fluid can be entrapped within the inflation arm 22 to render the catheter of the self-inflating type. It will be understood that if the retention bag of the catheter (is to be filled only through use of a syringe the inflation arm 22 need not be formed of an elastic material but may be formed of an essentially non-elastic plastic material such as a vinyl chloride polymer and may be an integral component of drainage tube 11. The mouth of the inflation arm 22 is maintained sealed by a plug 24,

or in the alternative by a valve which is biased to a closed position such as is shown in U.S. Patent 3,131,694.

The drainage tube 11 is formed of a flexible vinyl chloride polymer that contains a sufllcient amount of plasticizer for the vinyl chloride polymer to impart flexibility to the polymer. Illustrations of vinyl chloride polymers commercially available are polyvinyl chloride (a homopolymer of vinyl chloride) and copolymers of vinyl chloride copolymerized wtih a lesser amount of vinylidene chloride, vinyl acetate or maleic acid esters, although any vinyl chloride polymer comprised of a major proportion of bound vinyl chloride is suitable. Typical illustrations of vinyl chloride polymer plasticizers used for rendering the vinyl chloride polymer soft and flexible are dioctyl phthalate, butyl decyl phthalate, dioctyl adipate, dioctyl sebacate, tricresyl phosphate, trioctyl phosphate, didecyl phthalate and acetyl tributyl citrate.

The sleeve 16 (and the inflation arm 22 if it is desired that the inflation arm be elastic so that a quantity of inflating fluid can be entrapped within the inflation arm and expand the walls of the inflation arm if necessary) is formed of any elastic rubber composition, although a natural rubber composition is preferred because of the excellent elasticity of natural rubber.

The adhesion of the sleeve 16 to the drainage tube 11 and the adhesion of the elastic inflation arm 22 to the nipple 21 of inflation tube 19 is accomplished through a bond developed by an adhesive system suitable for adhering an elastic rubber to vinyl chloride polymer. The adhesive bond preferably is developed by first halogenating the surface of the elastic rubber which is to be bonded to the vinyl chloride polymer surface to improve the adhesion obtained. Thus, in the catheter shown in FIG. 1, it is preferable that at least the

inner surfaces

25, 26 of the

marginal zones

17, 17 of sleeve 16 and the inner surface 27 of the distal end 28 of the inflation arm 22 is halogenated, preferably chlorinated, before the sleeve 16 and inflation arm 22 are bonded to drainage tube 11 and nipple 21, respectively. In the alternative, the sleeve 16 and inflation arm 22 may be made in their entirety of an elastic halogenated rubber. The adhesive preferably employed for bonding the sleeve 16 to drainage tube 11 and for bonding the inflation arm 22 to nipple 21 cornprises diisocyanate-treated polyurethane (marketed under the trade designation Estane 5740X120). In adhering the sleeve 16 to the drainage tube 11, the adhesive is applied to the zones of the drainage tube to which it is desired to adhere the

marginal zones

17, 17 of the sleeve 16 and/o1' to the

inner surfaces

26, 26 of the

marginal zones

17, 17 of the sleeve 16. Thereafter, the sleeve is properly positioned on the drainage tube 11 with the

marginal zones

17, 17 of the sleeve 16 overlying the zones of the drainage tube 11 to which they are to be adhered. In like manner, the adhesive is applied to the exterior surface of nipple 21 of inflation tube 20 and/or to the inner surface 27 of the distal end 28 of the inflation arm 22 and the distal end of the inflation arm is disposed over nipple 21 of the inflation tube 20. The assembly thereafter is heated, if necessary or desirable, to cure the adhesive and develop the desired bond.

In the embodiment shown in FIG. 4, the catheter 30 is similar to the catheter of FIG. 1 in that the catheter 30 comprises an elongated flexible thin-walled vinyl chloride polymer lumen or drainage tube 31 which is rounded at its distal end 32 into a rounded closed tip 33 and is provided at its distal end with one or more lateral openings 34 connecting into the interior of drainage tube 31. Catheter 30 also is similar to catheter 10 (shown in FIG. 1) in that it is provided with a thin-walled elastic rubber sleeve or bag 35 adhered along its

marginal zones

36, 36 to the exterior surface of drainage tube 31 in the manner described above in referring to the manner of attachment of sleeve 16 of catheter 10 to the drainage tube 11 of catheter 10, and further is provided with a flexible inflation tube 37 disposed within drainage tube 31 and open- .4 ing at its distal end into the space formed between the central zone of sleeve 35 and the adjacent exterior surface of drainage tube 31. Catheter 30 differs from catheter 10 in that the proximal end 37 of drainage tube 31 of catheter 30 does not flare to provide a funnel-shaped opening for receiving a connector tube, as does drainage tube 11 of catheter 1i) but, instead, terminates short of the end of the catheter 30 and provides a hub 38 onto which an elastic rubber catheter head 39 is bonded.

Catheter head 39 is comprised of a hollow generally funnel-shaped component 40 connecting with the hollow interior of drainage tube 31 and forming an extension to said drainage tube 31 adapted to receive a connector tube for carrying away fluid drained from a patient with whom the catheter is being employed, and a hollow inllation arm 41 offset from the drainage tube 31 and the funnel-shaped component 40 of the catheter head and into which the proximal end 42 of the inflation tube 37 protrudes. The hub 38 of drainage tube 31 and the proximal end 42 of the inflation tube 37 are adhered to the adjacent inner surfaces of the elastic rubber catheter head 39 by adhesive 43. As indicated above in the description of the embodiment shown in FIG. 1, preferably the rubber surfaces of the catheter to be adhered to the vinyl chloride polymer components of the catheter are comprised of halogenated rubber and preferably the adhesive which is used comprises diisocyanate-treated polyurethane although any adhesive which will develop a sufllcient bond between the rubber surface and the vinyl chloride polymer surface, considering the use to which the catheter will be put, may be used.

Various modifications of the present invention will be apparent and it will be understood that it is not intended to limit this invention to the two embodiments described.

We claim:

1. An inflatable bag catheter comprising an elongated flexible thin-walled vinyl chloride polymer drainage tube open at its proximal end and having at least one lateral opening in its distal end, a thin-walled elastic rubber sleeve adjacent the distal end of said drainage tube, said sleeve being bonded with a-n adhesive along its marginal zones to the exterior surface of said drainage tube to form a fluid-tight seal along said marginal zones of said sleeve and being unattached to said drainage tube along its central region whereby the central region of said sleeve is free to expand laterally of said drainage tube upon the introduction of an inflating fluid into the space formed between the unattached central region of the sleeve and the exterior surface of the drainage tube adjacent thereto, the inner surfaces of the marginal zones of the said elastic rubber sleeve being comprised of halogenated rubber, a flexible inflation tube opening at its distal end into the space formed between the unattached central region of the said sleeve and the exterior surface of the drainage tube adjacent the central region of the said sleeve, the proximal end of said inflation tube communicating with a hollow elastic rubber inflation arm offset from the proximal end of said drainage tube, the distal end of the said inflation arm encompassing and being adhered to the proximal end of said inflation tube, the inner surface of the hollow inflation arm bonded to the proximal end of the inflation tube being comprised of halogenated rubber, the proximal end of said inflation arm being normally in a closed condition.

2. The catheter of claim 1 in which the inflation arm is made of natural rubber and in which the inner surface of the hollow inflation arm bonded to the proximal end of the inflation tube is comprised of chlorinated natural rubber.

3. The catheter of claim 2 in which the catheter is provided with an elastic rubber catheter head which is comprised of a hollow generally funnel-shaped component adhered to the proximal end of the drainage tube and a hollow inflation arm offset from the proximal end of the drainage tube and encompassing and adhered to the proximal end of the inflation tube, said elastic rubber catheter head being rnade of natural rubber, the 2,896,629 7/ 1959 Warr 128-349 inner surface of the catheter head "bonded to the proximal 3,058,472 10/ 1962 Thornton 128--348 end of the drainage tube and the inner Surface of the 3,112,748 12/ 1963 Colburn 128-350 catheter head bonded to the `proximal end of the infla- 3,144,868 8/1964 Jascalevich 128-350 tion tube being comprised of halogenated rubber. r 3,275,001 9/ 1966 Rosecrans 12S-349 4. The catheter of claim 1 in which the marginal o 3,292,627 12/ 1966 Harautuneian 128-349 zones of the sleeve are bonded to the exterior surfaces of the drainage tube with diisocyanate-treated polyure- OTHER REFERENCES thane.

References Cited 10 Lancet. Dec. 5, 1964, No. 7,371, p. 1218. UNITED STATES PATENTS DALTON L. TRULUCK, Primary Examiner 2,234,611 3/ 1941 Trumbull 161-242 X 2,930,377 3/1960 Cowley 128-344