US 3379197 A
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Aprll 23, 1968 R. 1.. HAYES 3,379,197
SELF-INFLATING CATHETER WITH MEANS TO PREVENT LEAKAGE OF INFLATION FLUID Filed Aug. 10, 1965 INVENTOR. ROBERT L. HAYES United States Patent Cflice 3,379,197 Patented Apr. 23, 1968 3,379,197 SELF-INFLATING CATHETER WITH MEANS TO PREVENT LEAKAGE 0F INFLATHQN FLUID Robert L. Hayes, Mount Holly, N.J., assignor to The B. F.
Goodrich Company, New York, N.Y., a corporation of New York Filed Aug. 10, 1965, 521'. No. 478,548 4 Claims. (Cl. 128-349) ABSTRACT OF THE DISCLOSURE The side inflation arm of a self-inflatable bag catheter (which has an inflating fluid under pressure confined within such inflation arm) is enclosed in a fluid-impervious envelope to deduce the diffusion loss of inflation fluid contained in the side inflation arm.
This invention pertains to a self-inflating bag catheter and pertains more particularly to a self-inflating bag catheter which has a measured quantity of inflating fluid entrapped Within the inflation arm at the proximal end of the catheter.
Inflatable bag catheters have been used commonly by physicians for many years to drain internal organs of patients. Specifically, 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 retention 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, it was customary to insert the distal end of the catheter into the organ to be drained and thereafter to inflate the inflatable retention bag of the catheter by introducing a required amount of inflating fluid (sterile water normally being used) into the inflation arm, either through use of a hypodermic syringe inserted through the plug in the inflation arm (when a plug is used) or by means of a syringe provided with a tip capable of opening the valve in the inflation arm (when a valve is employed). When it is desired to remove the catheter from the body of the patient, the inflating fluid which had been introduced into the catheter is withdrawn by once more introducing the hypodermic syringe or valve-opening syringe into the inflation arm and by withdrawing fluid until the retention bag is deflated sufliciently to permit the catheter to be withdrawn from the patient without undue discomfort.
The inflation of the retention bag of the catheter through use of a syringe while the catheter is inserted in the patient is awkward and inconvenient and, when a hypodermic syringe is employed, often results in the technician attending to the inflation of the retention bag being jabbed by the hypodermic needle when the needle inadvertently is caused to puncture the side wall of the inflation am. To eliminate the inconvenience attached to the inflation of the catheter bag in the manner described above while the catheter is inserted in the patient, a self-inflatable bag catheter which has suflicient inflating fluid releasably confined within the proximal end of the inflation arm for inflating the retention bag has been proposed. One such proposal for a self-inflating bag catheter employs a rupturable container housed within the inflation arm which upon rupture releases a gas in suflicient quantity to cause inflation of the bag (said proposal being described in detail in U.S. Patent No. 3,152,592).
A second proposal for a self-inflating bag catheter involves collapsing the inflation arm of the catheter with a clamp or clip at a location somewhat spaced from the plug or valve in the inflation arm that seals the mouth of the inflation arm, in order to provide a closed chamber between the clamp or clip and the plug or valve into which a suflicient quantity of inflating fluid to properly inflate the retention bag of the catheter is injected. After the catheter is inserted into the patient, all that one is required to do in order to inflate the retention bag is to remove the clamp or clip from the inflation arm. The inflating liquid thereupon flows down the inflation tube and into the inflatable retention bag until a condition of pressure equilibrium is reached. Provided that a suflicient amount of inflating fluid has been injected initially into the inflation arm, the inflatable retention bag will be expanded the proper degree to maintain the distal end of the catheter lodged within the cavity to be drained. It is in connection with this second proposal that this present invention pertains.
The difliculty which has been observed in connection with the self-inflating bag catheter into which a measured quantity of inflating fluid has been injected into the inflation arm in accordance with the second proposal described above is that the inflating liquid slowly difluses through the wall of the inflation arm whereby, unless the catheter is used within a short time after being filled and packaged, it must be returned for the injection of addi tional inflating fluid into the inflation arm of the catheter in order to provide proper inflation of the retention bag of the catheter when the clamp or clip is removed.
The present invention materially extends the period of time that the catheter can be stored before use without requiring the injection of additional inflating fluid into the inflation arm. In accordance with this invention, the inflation arm with inflating fluid confined therein is en cased in an envelope of a material that is essentially impervious to the transfer of the inflating fluid therethrough. The inflating fluid that diffuses initially through the wall of the inflation arm is entrapped within the envelope and soon the vapor pressure of the inflating fluid which has diffused into the envelope is suflicient that a condition of equilibrium is reached whereby theoretically further loss of inflating fluid from the inflation arm is eliminated. However, there generally is some loss of the vapor from within the envelope to the atmosphere as a result of slow diffusion of the vapor through the envelope, but such loss is slight and the catheter can be stored for upwards of a year or more before suflicient inflating fluid is lost from the inflation arm of the catheter to require the injection of additional inflating fluid into the inflation arm.
The invention will be more fully understood by referring to the following description of an embodiment of this invention and by referring to the drawing in which:
FIG. 1 is an elevation view, partly broken away and in section, of an inflatable bag catheter;
FIG. 2 is a partial elevation view of the catheter of FIG. 1 showing an open-ended envelope disposed over the inflation arm of the catheter;
FIG. 3 is a plan view of a clip for collapsing and closing the inflation arm of the catheter at a location spaced from the proximal end of the inflation arm;
FIG. 4 is a partial elevation View of the catheter of FIG. 1 showing the inflation arm collapsed and the open-ended envelope that had been disposed over the inflation arm closed at one end by the clip shown in FIG. 3 and showing a hypodermic syringe inserted through the plug of the inflation arm;
FIG. 5 is a partial elevation view similar to FIG. 4 except showing that portion of the inflation arm between the clip and the plug expanded after injection of inflating fluid thereinto and showing the hypodermic syringe withdrawn; and
FIG. 6 is a partial elevation view similar to FIG. 5 showing the top of the envelope sealed closed.
Referring to FIG. 1 of the drawing, the inflatable bag catheter 10 is comprised of an elongated flexible thinwalled hollow drainage tube 11 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 of the 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 sleeve or bag 16 is adhered along its marginal zones 17, 17 to the exterior surface of the drainage tube 11 to form fluid-tight seals. The central zone 18 of the sleeve 16 is unattached to the drainage tube 11 so that the central zone 18 can be expanded by inflating fluid into a bulbous contour (such as is shown in phantom in FIG. 1) in order to prevent the catheter from becoming inadvertently withdrawn from the patient. A flexible inflation tube 19 is disposed within drainage tube 11 and opens at its distal end into the space formed between the central zone 18 of the sleeve 16 and the adjacent exterior surface of the drainage tube 11. The inflation tube 19 emerges through the wall of drainage tube 11 in the region adjacent the proximal end 12 of drainage tube 11 and terminates in an elastic inflation arm 20 offset from the proximal end of the drainage tube 11. The mouth of the inflation arm 20 is maintained sealed by a plug 21, or in the alternative by a valve which is biased to a closed position such as is shown in US Patent 3,131,694.
It will be appreciated that if an inflating fluid, such as sterile water, is introduced under pressure into the inflation arm 20 the fluid will travel down the inflation tube 19 and into the space formed between the central zone 18 of the sleeve 16 and the exterior surface of the drainage tube 11 that is adjacent thereto and, since sleeve 16 is elastic, that if a suflicient quantity of inflating fluid is introduced into the inflation arm 20 the sleeve 16 will expand and assume a bulbous contour of suflicient size to retain the catheter within the cavity of the patient. Upon removal of the inflating fluid, the elasticity of the sleeve 16 will cause the sleeve 16 to return to its unexpanded condition and allow the catheter to be withdrawn from the patient.
The catheter 10 generally is formed of a natural or synthetic rubber or of a flexible plastic material, such as polyvinyl chloride or copolymers of vinyl chloride, that contain a suflicient amount of plasticizer to impart flexible properties to the plastic material. The sleeve 16 desirably is formed from natural rubber latex because of the excellent elasticity of natural rubber. Generally, no metal parts are employed in the catheter with the exception of the plug or valve used to seal the proximal end of the inflation arm 20 which plug or valve may contain one or more metal components.
To impart a self-inflating feature to the catheter 10 shown in FIG. 1, a clamp or clip 22 (such as the one shown in FIG. 3) is used to collapse the inflation arm 20 at a position spaced from the proximal end of the inflation arm 20 and to provide thereby a sealed chamber 23 in the inflation arm 20 between the plug (or valve) 21 and the clip or clamp 22 into which inflating fluid can he injected and confined. To prevent objectionable loss of inflating fluid resulting from diffusion of inflating fluid through the wall of the inflation arm 20 durim storage of the catheter before being used, a moisture impervious openended envelope 24 is positioned over the inflation arm 20 before the clip or clamp 22 is employed. The clip or clamp 22 then is positioned over the distal end of the envelope 24 and the inflation arm 20 which operation not only collapses the inflation arm 20 to prevent inflating fluid injected into the inflation arm 20 from entering the inflation tube 19 but also serves to close the open-end of envelope 24 that is confined between the prongs of the clip or clamp 22. inflating fluid then is injected into the sealed chamber 23 of the inflation arm 20 by means of a syringe 25 until a suflicient quantity of inflating fluid to cause proper inflation of the retention sleeve 16 upon release of the clip or clamp 22 has been introduced into the chamber 23 of the inflation arm 20. Since the inflation arm 20 is formed of an elastic material, the injection of the proper quantity of inflating fluid into the sealed chamber 23 of the inflation arm 20 will cause the wall of the inflation arm 20 to expand into a bulbous contour, as is shown in FIGS. 5 and 6. The proximal end 26 of the envelope 24 then is sealed closed along zone 27 in order to encase the chamber 23 filled with inflating fluid in the envelope 24.
The encasement of the portion of the inflation arm 20 within which the inflating fluid is confined with the mois ture-impervious envelope 24 allows the catheter to be stored for periods of up to a year or more before use with-t out objectionable loss of inflating fluid. When the envelope 24 was not used, suflicient inflating fluid was lost by diffusion through the wall of the inflation arm 20 within a three to four month storage period that it become necessary to inject additional fluid into the inflation arm 20 in order to obtain proper inflation of the retention sleeve 16.
The envelope 24 may be formed of any flexible material that is substantially impervious to the inflation fluid injected into the inflation arm 20, although preferably the envelope 24 is formed of a transparent material so that it can be determined by mere inspection without removal of the envelope 24 whether an objectionable loss of inflating fluid has occurred. An envelope 24 made from a flat tube of polyethylene having a wall thickness of 0.003 inch is quite suitable, for example. It will be appreciated that, for convenience, it is desirable that the material from i which the envelope 24 is formed be heat-scalable so that the proximal end 26 of the envelope 24 can be closed without difliculty, although a material that is not heatsealable can be used since the proximal end 26 of the envelope 24 can be closed by a mechanical closure.
1. In combination, a self-inflatable bag catheter comprisig an elongated flexible thin-walled drainage tube open at its proximal end and having at least one lateral opening in its distal end, a thin-walled elastic sleeve adjacent the distal end of said drainage tube, said sleeve being bonded 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 a inflating fluid into the space formed between the unattached central region of the sleeve and the exterior surface of the drainage tube adjacent thereto, 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 terminating in an elastic inflation arm offset from the proximal end of said drainage tube, means in the mouth of said inflation arm for maintaining the proximal end of the inflation arm normally closed, a fluidimpervious flexible envelope positioned over the said inflation arm, said envelope being closed at the sides and along its proximal end, means disposed over the distal end of said envelope and over said inflation arm at a location spaced from the proximal end of the inflation arm for collapsing and closing the passage of the inflation arm to form a sealed chamber in the inflation arm and for closing the distal end of said envelope, said sealed chamber in said inflation arm containing an inflating fluid under pressure in sufiicient quantity to cause inflation of the said sleeve adjacent the distal end of said drainage tube upon removal of the said means for collapsing and closing 10 310501066 the passage of the inflation arm.
2. The combination of claim 1 in which said envelope disposed over the said inflation arm is transparent.
3. The combination of claim 2 in which said envelope 5 sealed along its proximal end by a heat-seal.
References lited UNITED STATES PATENTS 8/1962 Koehn 128-349 3,190,291 6/1965 Foley 128-249 3,275,001 9/1966 Rosecrans 128349 3,235,069 2/1966 Bennett et al 20663.2
disposed over the said inflation arm is formed of a heat- 15 DALTON TRULUCK Primary Examiner